Artisential Monopolar Precise Dissector

The ArtiSential Monopolar Precise Dissector is a single-use laparoscopic instrument for tissue dissection, temporary grasping or clamping, and monopolar electrosurgical cutting and…

Registry build 21.09.26

The ArtiSential Monopolar Precise Dissector is a single-use laparoscopic instrument for tissue dissection, temporary grasping or clamping, and monopolar electrosurgical cutting and coagulation. It is used with an electrosurgical generator during appropriate endoscopic, gynecological and general surgical procedures.

The instrument has a dissector jaw, shaft and grip with a control ring. Moving the grip articulates the jaw in several directions, while the control ring opens or closes it. The electrode connector links the instrument to the generator for radiofrequency energy delivery.

Supply and Control

The instrument is supplied sterile after ethylene oxide sterilization. Jaw movement is controlled manually by the user, and radiofrequency current produces tissue heating for cutting or coagulation.

65manufacturers in China registered for this device type
9catalogue numbers in this listing
11510(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 Artisential Monopolar Precise Dissector
Listed by LivsMed Inc., South Korea
FDA product code GEI
Device type Electrosurgical, Cutting & Coagulation & Accessories
Device class Class 2
Regulation 21 CFR 878.4400
Establishment Manufacturer
510(k) K230539
Record published 2026-04-28
Record revised 2026-04-23 (version 3)

Specifications

Specifications
MRI safety MR Unsafe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Storage environment humidity up to 80 % RH; Storage environment temperature 1 to 30 °C
Sizes Outer diameter 8 mm; shaft length 250 to 450 mm; shaft length 25 to 250 cm

Catalogue Numbers

Catalogue numbers for Artisential Monopolar Precise Dissector
Catalogue number Size Status
AMD01L-LV Outer Diameter 8 mm In distribution
AMD01S-LV Outer Diameter 8 mm In distribution
AMD01S-FV Outer Diameter 8 mm In distribution
AMD01-FV Outer Diameter 8 mm In distribution
AMD01-L Outer Diameter 8 mm In distribution
AMD01L-FV Outer Diameter 8 mm In distribution
AMD01-LV Outer Diameter 8 mm In distribution
AMD01L-L Outer Diameter 8 mm In distribution
AMD01S-L Outer Diameter 8 mm 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
K250126 2025-10-21
K241138 2024-11-15
K240657 2024-06-06
K230498 2023-06-05
K230539 2023-04-27
K230499 2023-04-26
K220384 2022-02-24
K203580 2021-04-30
K200875 2020-06-17
K200501 2020-05-11
K190909 2020-02-13

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