DiLumen Ik Endolumenal Interventional Knife

The DiLumen IK is a sterile, disposable monopolar electrosurgical knife for marking, cutting, dissecting and cauterizing tissue in the digestive tract during endoscopy. It connects to an…

Registry build 21.09.26

The DiLumen IK is a sterile, disposable monopolar electrosurgical knife for marking, cutting, dissecting and cauterizing tissue in the digestive tract during endoscopy. It connects to an electrosurgical generator and is used with grounding pads to deliver high frequency current through its knife tip.

A pistol style handle controls a flexible shaft with an articulating distal section and a retractable stainless steel knife tip. The operator can rotate the shaft, extend or retract the tip, articulate the distal section and lock that articulation in position.

Listed Item

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

Saline Delivery

A luer lock connector on the handle accepts a standard syringe for sterile saline delivery. Saline can flush the knife tip or enter the submucosa to lift a mucosal lesion under direct endoscopic visualization. The instrument is intended for a single patient.

65manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (24), Zhejiang (13), Shanghai (10). 23 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GEI
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Hangzhou Kangji Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Amphenol Alden Products Company Shenzhen Guangdong Contract manufacturer 24
Hangzhou Endo Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19
Hong Qiangxing (Shen Zhen) Electronics Limited Shenzhen Guangdong Contract manufacturer 19
Shenzhen MED-Link Electronics Tech Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
ATL Technology DG,Ltd. Dongguan Guangdong Contract manufacturer 14
Jiangyin Sinbon Electronics Co Ltd Jiangyin Jiangsu Contract manufacturer 13
Guangzhou Huada Biotechnology Co., Ltd. Guangzhou Guangdong Contract manufacturer 9

Showing 12 of 65. All 65 manufacturers in China registered for Electrosurgical, Cutting & Coagulation & Accessories

Record

Regulatory record for DiLumen Ik Endolumenal Interventional Knife
Listed by Lumendi, LLC, United States
FDA product code GEI
Device type Electrosurgical, Cutting & Coagulation & Accessories
Device class Class 2
Regulation 21 CFR 878.4400
Establishment Specification developer, Complaint-file establishment, Manufacturer
510(k) K183112
Record published 2019-12-26
Record revised 2020-02-06 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for DiLumen Ik Endolumenal Interventional Knife
Catalogue number Size Status
DiLumen Ik 140 cm In distribution
DiLumen Ik 95 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Surgical Direct Surgical Direct, Inc. 5,729
Speedlock National Advanced Endoscopy Devices, Inc. 5,212
Stingray Surgical Products Stingray Surgical Products L.L.C. 4,647
Kirwan Kirwan Surgical Products, LLC. 1,901
Millennium Avalign Technologies, Inc. 1,779
DANmed Dannoritzer Medizintechnik GmbH & Co. KG 1,590
Elmed Elmed, Inc. 1,519
Symmetry Olsen Aspen Surgical Products, Inc. 1,219
Guenter Bissinger Medizintechnik GmbH Günter Bissinger Medizintechnik GmbH 1,117
Ambler Surgical Ambler Surgical, LLC 756
V. Mueller Steris Corporation 661
Aesculap Aesculap AG 544

Showing 12 of 2,922. All products under Electrosurgical, Cutting & Coagulation & Accessories

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K183112 2019-08-02
K173405 2018-05-22

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer