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DiLumen Ik Endolumenal Interventional Knife

FDA UDI

Class II (US FDA UDI)

by Lumendi Llc

Identity

Trade Name
DiLumen Ik Endolumenal Interventional Knife FDA UDI
Generic Name
Endoscopic electrosurgical submucosal lift/resection set FDA UDI
Device Name
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 FDA UDI
Model / Reference
DiLumen Ik 95 cm FDA UDI
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 FDA UDI

Identifiers

Catalog Number
D-3200 FDA UDI
Primary DI / UDI-DI
00858836007041 FDA UDI
510(k) Number
K183112 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Endoscopic electrosurgical submucosal lift/resection set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endoscopic electrosurgical submucosal lift/resection set

DiLumen Ik Endolumenal Interventional Knife by Lumendi Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic electrosurgical submucosal lift/resection set.

Cleared under the same submission

K183112 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lumendi Llc

Sources (1)

  • FDA UDI 1d6fab48-a9fe-4592-ad7a-c1c54fdcc8aa 36 fields · synced Jun 8, 2026