lumendi.comDiLumen C1, EZ1 and Tool Mount
Lumendi, LLC
LUMENDI, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013505983 | 3013505983 | LUMENDI, LLC | 1 | N | 2026-01-01 | 253 Post Road W Westport CT US 06880 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00858836007164 | DiLumen C1, 130 cm - The Lumendi DiLumen C1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment. The DiLumen C1 consists of a soft flexible sheath that fits over standard endoscopes. The device employs a single balloon behind the bending section of the endoscope. When the balloon is inflated it contacts the intestine wall and provides stability to the endoscope. The device also has one integrated, flexible tool channel that provides access at the therapeutic site to use flexible endoscopic tools such as graspers, scissors, knives, etc., to perform endoluminal interventions. | 8444810822 | info@lumendi.com |
| 00858836007171 | DiLumen EZ1, 130 cm - The Lumendi DiLumen EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment. The DiLumen EZ1 consists of a soft flexible sheath that fits over standard endoscopes. The device employs a single balloon behind the bending section of the endoscope. When the balloon is inflated it contacts the intestine wall and provides stability to the endoscope. | 8444810822 | info@lumendi.com |
| 00858836007188 | DiLumen C1, 103 cm - The Lumendi DiLumen C1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment. The DiLumen C1 consists of a soft flexible sheath that fits over standard endoscopes. The device employs a single balloon behind the bending section of the endoscope. When the balloon is inflated it contacts the intestine wall and provides stability to the endoscope. The device also has one integrated, flexible tool channel that provides access at the therapeutic site to use flexible endoscopic tools such as graspers, scissors, knives, etc., to perform endoluminal interventions. | 8444810822 | info@lumendi.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 205476 | 1918866193 | K221452 | DiLumen C1, EZ1 and Tool Mount | FDF | 2023-02-10 |
| 205476 | 1959725385 | K211819 | DiLumen C2 and Tool Mount | FDF | 2021-10-22 |
| 205476 | 1421436683 | K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | FDF | 2021-04-21 |
| 205476 | 2056410337 | K183112 | DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) | GEI | 2019-08-02 |
| 205476 | 2067190449 | K182540 | DiLumen Endolumenal Interventional Platform | FDF | 2018-10-30 |
| 205476 | 1231816629 | K173405 | DiLumen Endolumenal Interventional Scissors (DiLumen Is) | GEI | 2018-05-22 |
| 205476 | 1590041773 | K173317 | DiLumen C2; DiLumen Tool Mount | FDF | 2018-04-17 |
| 205476 | 1738174925 | K162428 | DiLumen Endolumenal Interventional Platform | FDF | 2016-12-06 |
| 205476 | 2036230196 |
Product Codes Associated With Registrations#
PMN#
DiLumen C2 And Tool Mount
Lumendi, LLC
DiLumen Endolumenal Interventional Platform (DiLumen)
Lumendi, LLC
DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)
Lumendi, LLC
DiLumen Endolumenal Interventional Platform
Lumendi, LLC
DiLumen Endolumenal Interventional Scissors (DiLumen Is)
Lumendi, LLC
DiLumen C2; DiLumen Tool Mount
Lumendi, LLC
DiLumen Endolumenal Interventional Platform
Lumendi, LLC
GUDID#
DiLumen Interventional Grasper - 125 cm long flexible shaft grasper with elbow bending section and articulating distal tip
2026-08-07
DiLumen Interventional Grasper - 125 cm flexible shaft grasper with elbow bending section and articulating distal tip
2020-08-25
DiLumen Ig Interventional Grasper - The DiLumen Endoluminal Interventional Grasper is a sterile, single use, disposable device intended to be used for grasping and manipulating tissue within the digestive tract under direct endoscopic visualization. The DiLumen Ig utilizes a pistol style handle, flexible 5mm shaft with an articulating section at the distal end and jaws that have DeBakey pattern teeth to allow one-handed operation for secure grasping and manipulation of tissue during endoscopic procedures. The DiLumen Ig handle incorporates controls that allow the user to rotate the shaft in a specific plane, rotate the jaws 360 degrees, articulate the distal end of the shaft, open and close the jaws, and lock the articulation in a fixed position.
2018-12-14
DiLumen Ig Interventional Grasper - The DiLumen Endoluminal Interventional Grasper is a sterile, single use, disposable device intended to be used for grasping and manipulating tissue within the digestive tract under direct endoscopic visualization. The DiLumen Ig utilizes a pistol style handle, flexible 5mm shaft with an articulating section at the distal end and jaws that have DeBakey pattern teeth to allow one-handed operation for secure grasping and manipulation of tissue during endoscopic procedures. The DiLumen Ig handle incorporates controls that allow the user to rotate the shaft in a specific plane, rotate the jaws 360 degrees, articulate the distal end of the shaft, open and close the jaws, and lock the articulation in a fixed position.
2018-12-14
DiLumen C1, 130 cm - The Lumendi DiLumen C1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment. The DiLumen C1 consists of a soft flexible sheath that fits over standard endoscopes. The device employs a single balloon behind the bending section of the endoscope. When the balloon is inflated it contacts the intestine wall and provides stability to the endoscope. The device also has one integrated, flexible tool channel that provides access at the therapeutic site to use flexible endoscopic tools such as graspers, scissors, knives, etc., to perform endoluminal interventions.
2023-05-01
DiLumen EZ1, 130 cm - The Lumendi DiLumen EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment. The DiLumen EZ1 consists of a soft flexible sheath that fits over standard endoscopes. The device employs a single balloon behind the bending section of the endoscope. When the balloon is inflated it contacts the intestine wall and provides stability to the endoscope.
2023-05-01
DiLumen C1, 103 cm - The Lumendi DiLumen C1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment. The DiLumen C1 consists of a soft flexible sheath that fits over standard endoscopes. The device employs a single balloon behind the bending section of the endoscope. When the balloon is inflated it contacts the intestine wall and provides stability to the endoscope. The device also has one integrated, flexible tool channel that provides access at the therapeutic site to use flexible endoscopic tools such as graspers, scissors, knives, etc., to perform endoluminal interventions.
2023-05-01
DiLumen EZ1, 103 cm - The Lumendi DiLumen EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment. The DiLumen EZ1 consists of a soft flexible sheath that fits over standard endoscopes. The device employs a single balloon behind the bending section of the endoscope. When the balloon is inflated it contacts the intestine wall and provides stability to the endoscope.
2023-05-01
DiLumen Ik Endolumenal Interventional Knife - The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, disposable monopolar electrosurgical device intended to be used for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. The device is also indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions under direct endoscopic visualization. The DiLumen Ik utilizes a pistol style Handle, a Flexible Shaft with an articulating section at its distal end, and a stainless-steel Knife Tip that can be extended and retracted. The Handle incorporates controls that allow the clinician to rotate the Shaft, extend or retract the Knife Tip, articulate the distal end of the Shaft in a specific plane, and lock the articulation in a fixed position. There is also a female Luer Lock connector on the Handle that can be used with a standard luer lock syringe to introduce sterile saline at the distal end for flushing tissue debris from the knife tip or creating a bleb to lift mucosal lesions
2019-12-26
DiLumen Ik Endolumenal Interventional Knife - The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, disposable monopolar electrosurgical device intended to be used for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. The device is also indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions under direct endoscopic visualization. The DiLumen Ik utilizes a pistol style Handle, a Flexible Shaft with an articulating section at its distal end, and a stainless-steel Knife Tip that can be extended and retracted. The Handle incorporates controls that allow the clinician to rotate the Shaft, extend or retract the Knife Tip, articulate the distal end of the Shaft in a specific plane, and lock the articulation in a fixed position. There is also a female Luer Lock connector on the Handle that can be used with a standard luer lock syringe to introduce sterile saline at the distal end for flushing tissue debris from the knife tip or creating a bleb to lift mucosal lesions
2019-12-26
DiLumen C2 - DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. The device also has two flexible tool channels attached on the outside of the sleeve at the 3 and 6 o'clock positions. These tool channels accommodate flexible endoscopic instruments used to perform endoscopic interventions. This version DiLumen C2 is designed to work with the DiLumen Elbow Ig.
2019-12-26
DiLumen C2 - DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. The device also has two flexible tool channels attached on the outside of the sleeve at the 3 and 6 o'clock positions. These tool channels accommodate flexible endoscopic instruments used to perform endoscopic interventions. This DiLumen C2 version is designed to be used with the DiLumen Elbow Ig grasper.
2019-12-26
DiLumen Im Interventional Tool Mount - "The DiLumen Interventional Tool Mount (""DiLumen Im"") is a dedicated accessory for the DiLumen C2 that facilitates use of the DiLumen C2 tool channels by holding these channels in a fixed position. The Tool Mount consists of the FISSO Holding System with an added, permanently attached stainless steel tool bar to firmly hold the DiLumen C2 tool channels in the clinician’s preferred orientation. The Tool Mount and holding system is attached to a standard surgical table rail using a rail clamp."
2018-12-19
DiLumen Endolumenal Interventional Platform, 103 cm - DiLumen consists of a soft flexible sheath that fits over standard colonoscopes. The device employs two balloons, one behind the bending section of the colonoscope and the second in front of the tip of the colonoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area.
2018-12-19
DiLumen Endolumenal Interventional Platform, 130 cm - DiLumen consists of a soft flexible sheath that fits over standard colonoscopes. The device employs two balloons, one behind the bending section of the colonoscope and the second in front of the tip of the colonoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area.
2018-12-19
DiLumen Endolumenal Interventional Platform, 103 cm - DiLumen consists of a soft flexible sheath that fits over standard colonoscopes. The device employs two balloons, one behind the bending section of the colonoscope and the second in front of the tip of the colonoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area.
2018-12-19
DiLumen C2 - DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. The device also has two flexible tool channels attached on the outside of the sleeve at the 3 and 6 o'clock positions. These tool channels accommodate flexible endoscopic instruments used to perform endoscopic interventions.
2018-12-14
DiLumen C2 - DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. The device also has two flexible tool channels attached on the outside of the sleeve at the 3 and 6 o'clock positions. These tool channels accommodate flexible endoscopic instruments used to perform endoscopic interventions.
2018-12-14
DiLumen C2 - DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. The device also has two flexible tool channels attached on the outside of the sleeve at the 3 and 6 o'clock positions. These tool channels accommodate flexible endoscopic instruments used to perform endoscopic interventions.
2018-12-14
DiLumen C2 - DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. The device also has two flexible tool channels attached on the outside of the sleeve at the 3 and 6 o'clock positions. These tool channels accommodate flexible endoscopic instruments used to perform endoscopic interventions.
2018-12-14
DiLumen C2 - DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. The device also has two flexible tool channels attached on the outside of the sleeve at the 3 and 6 o'clock positions. These tool channels accommodate flexible endoscopic instruments used to perform endoscopic interventions.
2018-12-14
DiLumen C2 - DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. The device also has two flexible tool channels attached on the outside of the sleeve at the 3 and 6 o'clock positions. These tool channels accommodate flexible endoscopic instruments used to perform endoscopic interventions.
2018-12-14
DiLumen Is Endolumenal Interventional Scissors - The DiLumen Is is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible 5mm shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. The DiLumen Is has a plug at the bottom of the handle that can be used to connect the device to an electrosurgical generator via a dedicated cord. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically
2018-12-14
DiLumen Is Endolumenal Interventional Scissors - The DiLumen Is is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible 5mm shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. The DiLumen Is has a plug at the bottom of the handle that can be used to connect the device to an electrosurgical generator via a dedicated cord. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically
2018-12-14
DiLumen Endolumenal Interventional Platform - DiLumen consists of a soft flexible sheath that fits over standard colonoscopes. The device employs two balloons, one behind the bending section of the colonoscope and the second in front of the tip of the colonoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area.
2017-06-13