DiLumen Ik Endolumenal Interventional Knife

Primary DI
00858836007058
Brand
DiLumen Ik Endolumenal Interventional Knife
Company
LUMENDI LLC
Model
DiLumen Ik 140 cm
Catalog number
D-3201
Device description
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
Published
2019-12-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183112000DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)Lumendi, LLC2019-08-02GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858836007058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858836007058008588360070588588360070580858836007058

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical submucosal lift/resection setA collection of devices designed to be used during an endoscopic mucosal resection procedure to: 1) lift a section of diseased mucosa by injection of a submucosal lifting solution; and 2) resect the lesion using monopolar electrosurgical energy; it may in addition include devices designed to perform vacuum elevation of the lesion to supplement submucosal lifting. It includes a submucosal injection needle, an electrosurgical electrode (e.g., polyp snare), and might include additional supportive devices such as a dye spray catheter and endoscope suction cap. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8444810822info@lumendi.com

Regulatory Flags#

DUNS number
859290897
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858836007126DiLumen Interventional GrasperIgE 125cmD-30102026-08-07
00858836007102DiLumen Interventional GrasperIgE 125cmD-30102020-08-25
00865309000256DiLumen Ig Interventional GrasperDiLumen Ig 140 cmD-30012018-12-14
00865309000287DiLumen Ig Interventional GrasperDiLumen Ig 95 cmD-30002018-12-14
00858836007164DiLumen C1, 130 cmDiLumen C1, 130 cmD-21002023-05-01
00858836007171DiLumen EZ1, 130 cmDiLumen EZ1, 130 cmD-11002023-05-01
00858836007188DiLumen C1, 103 cmDiLumen C1, 103 cmD-21012023-05-01
00858836007195DiLumen EZ1, 103 cmDiLumen EZ1, 103 cmD-11012023-05-01
00858836007041DiLumen Ik Endolumenal Interventional KnifeDiLumen Ik 95 cmD-32002019-12-26
00858836007065DiLumen C2DiLumen C2.2 130 cmD-20042019-12-26
00858836007089DiLumen C2DiLumen C2.2 103 cmD-20052019-12-26
00858836007003DiLumen Im Interventional Tool MountDiLumen ImD-40002018-12-19
00865309000232DiLumen Endolumenal Interventional Platform, 103 cmDiLumen, 103 cmD-10022018-12-19
00865309000225DiLumen Endolumenal Interventional Platform, 130 cmDiLumen, 130 cmD-10012018-12-19
10865309000239DiLumen Endolumenal Interventional Platform, 103 cmDiLumen, 103 cmD-10022018-12-19
00858836007027DiLumen C2DiLumen C2 130 cmD-20012018-12-14
00858836007034DiLumen C2DiLumen C2 103 cmD-20022018-12-14
00865309000249DiLumen C2DiLumen C2 168 cmD-20002018-12-14
10858836007024DiLumen C2DiLumen C2 130 cmD-20012018-12-14
10858836007031DiLumen C2DiLumen C2 103 cmD-20022018-12-14

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