Bipolar Forceps

Bipolar Forceps 7.8CM, 0.4MM, Angled TIP

Registry build 21.09.26
65manufacturers in China registered for this device type
20catalogue numbers in this listing
5510(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 Bipolar Forceps
Listed by Cynosure, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k) K964176
Record published 2016-09-21
Record revised 2023-01-11 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Bipolar Forceps
Catalogue number Size Status
J20 In distribution
J11 In distribution
J21 In distribution
J7D In distribution
J5 In distribution
J7U In distribution
J4 In distribution
J1 In distribution
J10 In distribution
J13 In distribution
J17 In distribution
J3 In distribution
J1B In distribution
J2 In distribution
J8 In distribution
J7 In distribution
J18 In distribution
J19 In distribution
J9 In distribution
J12 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
K223292 2022-11-23
K212891 2022-03-18
K190678 2019-07-24
K182365 2018-10-24
K171262 2017-09-22

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