Kirwan (Distributor Gyrus Acmi)
Bipolar Bayonet Tonsil Forceps Non-Stick Angled Tips Insulated, Reusable 1.5mm Tips, Length 7.5"
65manufacturers in China registered for this device type
9catalogue numbers in this listing
11510(k) clearances naming this product code
7recalls on this 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.
| 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 | Kirwan Surgical Products, LLC., United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Manufacturer |
| 510(k) | K811820 |
| Record published | 2016-06-26 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 3.5 to 7.5 in; length 12 ft |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 13-1503 | Length 5 in | In distribution |
| 13-1509 | Length 12 ft | In distribution |
| 13-1506 | Length 5.5 in | In distribution |
| 13-1504 | Length 5 in | In distribution |
| 13-1505 | Length 5.5 in | In distribution |
| 13-1501 | Length 3.5 in | In distribution |
| 13-1507 | Length 7.5 in | In distribution |
| 13-1502 | Length 3.5 in | In distribution |
| 13-1508 | Length 7.5 in | 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 |
|---|---|
| K231872 | 2023-08-25 |
| K052203 | 2005-10-20 |
| K023482 | 2003-01-15 |
| K992218 | 1999-07-30 |
| K982176 | 1998-09-18 |
| K971341 | 1997-05-22 |
| K965241 | 1997-02-28 |
| K962678 | 1996-08-14 |
| K960455 | 1996-02-27 |
| K913514 | 1991-11-05 |
| K900533 | 1990-04-09 |
Recalls
7 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-11-14 | Class I | Device Design | Potential for the outer stainless-steel tube to break or detach. | 66 units |
| 2024-11-14 | Class I | Device Design | Potential for the outer stainless-steel tube to break or detach. | 4,470 units |
| 2024-11-14 | Class I | Device Design | Potential for the outer stainless-steel tube to break or detach. | 925 units |
| 2024-11-14 | Class I | Device Design | Potential for the outer stainless-steel tube to break or detach. | 3,010 units |
| 2024-11-14 | Class I | Device Design | Potential for the outer stainless-steel tube to break or detach. | 800 units |
| 2024-11-14 | Class I | Device Design | Potential for the outer stainless-steel tube to break or detach. | 2,999 units |
| 2024-11-14 | Class I | Device Design | Potential for the outer stainless-steel tube to break or detach. | 80,060 units |
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.