KIT KE201 Cole
Kit Contains: C2201, 120MM INSUFF NEEDLE XE, 20/BX CTF12, 5x100 Kii Fios ZTHR DP 10/BX CTF33, 11x100 Kii Fios ZTHR 6/BX CTS12, 11x100 Kii SLEEVE ZTHR 12/BX CA090, DIRECT DRIVE LCA 3/BX…
Kit Contains: C2201, 120MM INSUFF NEEDLE XE, 20/BX CTF12, 5×100 Kii Fios ZTHR DP 10/BX CTF33, 11×100 Kii Fios ZTHR 6/BX CTS12, 11×100 Kii SLEEVE ZTHR 12/BX CA090, DIRECT DRIVE LCA 3/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX CY010, 5mmX35cm EPIX LAPA DISSECT, 10/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX
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.
| 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
| Listed by | Applied Medical Resources Corp., United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2015-10-09 |
| Record revised | 2024-08-07 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GK257 | In distribution |
Same 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
| Clearance | Decision date |
|---|---|
| K252740 | 2025-11-04 |
| K252412 | 2025-10-31 |
| K222284 | 2022-10-14 |
| K201212 | 2020-06-05 |
| K200598 | 2020-04-08 |
| K193292 | 2019-12-20 |
| K182653 | 2018-11-14 |
| K182244 | 2018-10-11 |
| K180699 | 2018-04-13 |
| K172624 | 2018-02-13 |
| K171684 | 2017-08-07 |
| K162676 | 2016-12-01 |
| K153017 | 2016-07-06 |
| K153288 | 2016-06-01 |
| K151480 | 2016-02-19 |
| K143536 | 2015-04-16 |
| K143517 | 2015-03-27 |
| K141288 | 2014-08-22 |
| K132300 | 2014-01-24 |
| K103282 | 2010-11-16 |
| K925984 | 1993-06-17 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-12-12 | Class II | Device Design | Unintentional shifting of the tip insulation of the firm’s electrosurgical probes. | 28 units Domestically – 112 units Internationally | 2021-01-22 |
| 2015-07-31 | Class II | Device Design | Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery. | 101 units (U.S) and 38 units (International) | 2015-11-20 |
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.