creomedical.comSpydrBlade Flex Instrument (PRD-RG1-001)
Creo Medical, Ltd.
CREO MEDICAL, INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3019645223 | 3019645223 | CREO MEDICAL, INC | 1 | Y | 2026-01-01 | 100 Reserve Road Suite B400 Danbury CT US 06810 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 05060359560100 | Footswitch - Footswitch accessory for use only with the CROMA Electrosurgical Generators. | +441291637300 | customerservice@creomedical.com |
| 05060359560100 | Footswitch - Footswitch accessory for use only with the CROMA Electrosurgical Generators. | +18662261170 | uscustomerservice@creomedical.com |
| 05060359560209 | MicroBlate Flex - The AB1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue. Dimensions: 1.00 m long with a diameter of 2.00 mm | +18662261170 | uscustomerservice@creomedical.com |
| 05060359560209 | MicroBlate Flex - The AB1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue. Dimensions: 1.00 m long with a diameter of 2.00 mm | +441291637300 | customerservice@creomedical.com |
| 05060359560223 | SlypSeal Flex - HS1 is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites will include the following:• Peptic Ulcers• Dieulafoy Lesions• Mallory-Weiss Tears• Bleeding Polyp Stalks• Arteriovenous Malformations (AVMs)• AngiomataThe HS1 also has irrigation capability. Any other use is not recommended. | +441291637300 | customerservice@creomedical.com |
| 05060359560223 | SlypSeal Flex - HS1 is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites will include the following:• Peptic Ulcers• Dieulafoy Lesions• Mallory-Weiss Tears• Bleeding Polyp Stalks• Arteriovenous Malformations (AVMs)• AngiomataThe HS1 also has irrigation capability. Any other use is not recommended. | +18662261170 | uscustomerservice@creomedical.com |
| 05060359560292 | CROMA Electrosurgical Generator - A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery. | +441291637300 | customerservice@creomedical.com |
PMN#
CROMA Electrosurgical Generator (PRD-EMR-050)
Creo Medical, Ltd.
Reusable Interface Cable 1.5 m (PRD-IFC-002)
Creo Medical, Ltd.
Speedboat Flush SB1 Instrument
Creo Medical, Ltd.
AB1 Electrosurgical Instrument, Creo Electrosurgical System
Creo Medical, Ltd.
Creo Electrosurgical System with NP1 Instrument
Creo Medical, Ltd.
ABI Instrument, Creo Electrosurgical System
Creo Medical, Ltd.
NP1 Instrument, Creo Electrosurgical System
Creo Medical Ltd.
Creo Electrosurgical System With HS1 Hemostasis Accessory
Creo Medical Ltd.
Creo Medical Electrosurgical System Including Speedboat RS2 Surgical Accessory
Creo Medical Ltd
GUDID#
Footswitch - Footswitch accessory for use only with the CROMA Electrosurgical Generators.
2026-04-17
MicroBlate Flex - The AB1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue. Dimensions: 1.00 m long with a diameter of 2.00 mm
2021-07-29
Croma Generator - A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
2024-01-09
Speedboat RS2 8 Fr Instrument - A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosurgical current in a bipolar configuration to tissues for cutting; and 3) microwave energy to tissues for coagulation. It is typically intended to treat gastrointestinal mucosal polyps/lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It includes a submucosal injection needle, an electrosurgical electrode, and a microwave tip, connected by a flexible sheath to a handpiece which includes controls (e.g., needle deployment control)/solution injection port. This is a single-use device.
2023-11-08
Speedboat Ultraslim Long - Speedboat is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasis, cauterization) of soft tissue using microwaveenergy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract
2023-12-06
CROMA Electrosurgical Generator - The Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories.
2024-10-08
CROMA Electrosurgical Generator - A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
2021-03-15
SlypSeal Flex - HS1 is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites will include the following:• Peptic Ulcers• Dieulafoy Lesions• Mallory-Weiss Tears• Bleeding Polyp Stalks• Arteriovenous Malformations (AVMs)• AngiomataThe HS1 also has irrigation capability. Any other use is not recommended.
2020-12-31
Interface Cable, single use, 1.5 m - A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.
2020-11-23
Speedboat Inject 10 Fr - Intended for use in the cutting of soft tissue using radiofrequency current, the coagulation (hemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract.
2018-11-14
Procedure Pack Interface Cable, single use, 1.5 m - A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.
2018-11-15
CROMA Electrosurgical Generator with Footswitch - A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
2018-11-15
CROMA Electrosurgical Generator - Intended for use in the cutting of soft tissue using radiofrequency current, the coagulation (hemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract.
2019-03-20
Speedboat UltraSlim Short - Speedboat is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract.
2025-10-03
Speedboat Notch Short - Speedboat is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract.
2025-10-03
SpydrBlade Flex - SpydrBlade Flex is indicated for use in the cutting (incision, dissection, avulsion) of soft tissue using radiofrequency current and the coagulation (hemostasis, cauterization, ablation, arrest of bleeding) of soft tissue using microwave energy in the gastrointestinal tract as required or encountered in endoscopic procedures.
2025-06-12
MicroBlate Fine - MicroBlate Fine (NP1) is a single-use, sterile electrosurgical instrument for use with the Creo Medical Electrosurgical system. It enables ablation of potential malignant lesionssuch as nodules or tumors. MicroBlate Fine, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.
2025-05-05
MicroBlate Fine - MicroBlate Fine (NP1) is a single-use, sterile electrosurgical instrument for use with the Creo Medical Electrosurgical system. It enables ablation of potential malignant lesions such as nodules or tumors. MicroBlate Fine, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.
2025-05-05
Speedboat Notch Long - Speedboat Notch is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasis, cauterization) of soft tissue using microwaveenergy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract
2025-03-26
CROMA Electrosurgical Generator - The CROMA Electrosurgical Generator is a tabletop, non-network connected, mains powered Electrosurgical Unit (ESU). The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories.The Creo Medical Electrosurgical System is not intended for use in cardiac procedures.
2025-02-10
CROMA Electrosurgical Generator - The CROMA Electrosurgical Generator is a tabletop, non-network connected, mains powered Electrosurgical Unit (ESU). The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories. The Creo Medical Electrosurgical System is not intended for use in cardiac procedures.
2025-02-10
Reusable Interface Cable, 1.5 m - The Reusable Interface Cable is only for connection of compatible Creo Medical Instruments (Surgical Accessories) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave energy for the cutting, coagulation and ablation via endoscopic access.
2024-08-30
Croma Generator - A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
2024-10-08
Reusable Interface Cable, 1.5 m - The Reusable Interface Cable is only for connection of compatible Creo Medical Instruments (Surgical Accessories) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave energy for the cutting, coagulation and ablation of gastrointestinal tissue.
2024-08-30
Speedboat Ultraslim (SB1L) Electrosurgical Instrument - Speedboat UltraSlim is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract
2023-12-06
Speedboat RS2 8 Fr Instrument - A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosurgical current in a bipolar configuration to tissues for cutting; and 3) microwave energy to tissues for coagulation. It is typically intended to treat gastrointestinal mucosal polyps/lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It includes a submucosal injection needle, an electrosurgical electrode, and a microwave tip, connected by a flexible sheath to a handpiece which includes controls (e.g., needle deployment control)/solution injection port. This is a single-use device.
2023-11-08
Microblate Flex - The AB1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue. 1.00 m long with a diameter of 2.00 mm
2021-07-29