Kirwan
9 3/4" Reusable Bipolar Forceps, Tines Reduced 20%, Parallel Tines Identical to MIS Style, Ball/Socket Soft Stop, 0.7mm Tips, Angled Up 90 Deg. for 3mm, 2mm in Contact When Closed, Cup…
9 3/4″ Reusable Bipolar Forceps, Tines Reduced 20%, Parallel Tines Identical to MIS Style, Ball/Socket Soft Stop, 0.7mm Tips, Angled Up 90 Deg. for 3mm, 2mm in Contact When Closed, Cup Marked “TS3-L” (Special)
65manufacturers in China registered for this device type
1,901catalogue 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 | 2016-05-15 |
| Record revised | 2018-07-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| 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, manufacturing date, serial number |
| Packaging | Pack of 5, pack of 10, pack of 25, pack of 50, chipboard box of 10 |
| Sizes | Length 3.38 to 15.75 in; length 6 to 25 ft; length 1.9 to 5 m; length 14 to 33 cm; height 4.75 in |
| Distribution end date | 2023-11-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 21-1413AU | Length 7 in | In distribution |
| 19-1231IR | Length 8.5 in | In distribution |
| 12-1435AU | Length 8.75 in | In distribution |
| 10-6025S | In distribution | |
| 12-1635AUS | In distribution | |
| 16-1090 | Length 4 in | In distribution |
| 10-3415AUS | In distribution | |
| 14-9031 | Length 11 in | In distribution |
| 24-1457AUS | In distribution | |
| 19-1235C | Length 10 in | In distribution |
| 10-2402AU | Length 7 in | In distribution |
| 12-1445AUS | In distribution | |
| 24-1450EAU | Length 8.75 in | In distribution |
| 12-1195AU | Length 4.25 in | In distribution |
| 10-2200NSS | In distribution | |
| 19-8021C | Length 9 in | In distribution |
| 21-1421AUS | In distribution | |
| 20-1410AU | Length 6.25 in | In distribution |
| 18-1040 | Length 5.5 in | In distribution |
| 28-2600 | In distribution | |
| 30-2002S | In distribution | |
| 10-5100AU | Length 8.75 in | In distribution |
| 12-1235NSS | In distribution | |
| 21-1418AUS | In distribution | |
| 12-1235NSS | In distribution | |
| 24-1461EAU | Length 10 in | In distribution |
| 11-1403AUS | In distribution | |
| 10-2404AUS | In distribution | |
| 11-1402AUS | In distribution | |
| 21-1428EAU | Length 10.25 in | In distribution |
| 10-2200NSS | In distribution | |
| 21-1411AUS | In distribution | |
| 12-1432AUS | In distribution | |
| 20-1618AUS | In distribution | |
| 21-1419AUS | In distribution | |
| 21-1424EAU | Length 9.25 in | In distribution |
| 12-1200NSS | In distribution | |
| 20-1616AUS | In distribution | |
| 23-1415AUS | In distribution | |
| 20-1613AUS | In distribution | |
| 22-1454PL | Length 8.75 in | In distribution |
| 10-5404AUS | In distribution | |
| 20-1419AUS | In distribution | |
| 12-5100AUS | In distribution | |
| 10-2100AUS | In distribution | |
| 21-1413AUS | In distribution | |
| 19-1003AU | Length 7.75 in | In distribution |
| 24-1454AU | Length 8.75 in | In distribution |
| 12-1635AUS | In distribution | |
| 19-3010C | Length 5 in | In distribution |
| 20-1414EAU | Length 7.13 in | In distribution |
| 15-5104 | Length 8.75 in | In distribution |
| 20-1413EAU | Length 6.25 in | In distribution |
| 19-2004AUX | Length 7.5 in | In distribution |
| 18241-M976 | In distribution | |
| 15-5110 | Length 6 in | In distribution |
| 24-1458AUS | In distribution | |
| 11-1002S | In distribution | |
| 14-7002 | Length 4.25 in | In distribution |
| 20-1415NS | Length 7.13 in | In distribution |
| 21-1429EAU | Length 10.25 in | In distribution |
| 10-1633AU | Length 7.75 in | In distribution |
| 10-5402AUS | In distribution | |
| 10-1603NS | Length 7.75 in | In distribution |
| 10-5605NS | Length 8.75 in | In distribution |
| 20-1311S | In distribution | |
| 18271-M968 | Length 5 in | In distribution |
| 14-9044 | Length 7.5 in | In distribution |
| 24-1440EAU | Length 8 in | In distribution |
| 10-3402AUS | In distribution | |
| 18-1075 | Length 3.38 in | In distribution |
| 22-1463PL | Length 10 in | In distribution |
| 12-1600AUS | In distribution | |
| 10-4602 | In distribution | |
| 20-1413AU | Length 6.25 in | In distribution |
| 16-1413 | Length 7.5 in | In distribution |
| 12-1400AUS | In distribution | |
| 12-1275NS | Length 3.5 in | In distribution |
| 10-4021V | Length 16 ft | In distribution |
| 11-1403AUS | In distribution | |
| 12-1626AU | Length 8.25 in | In distribution |
| 21-1425EAUS | In distribution | |
| 21-1443EAU | Length 7 in | In distribution |
| 20-1618AUS | In distribution | |
| 12-1634AU | Length 8.75 in | In distribution |
| 20-1420AU | Length 7.88 in | In distribution |
| 15-5112S | In distribution | |
| 12-1600AUS | In distribution | |
| 10-2604AUS | In distribution | |
| 10-2404AUS | In distribution | |
| 20-1411AUS | Length 5 in | In distribution |
| 12-1436EAU | Length 9.63 in | In distribution |
| 21-1418AUS | In distribution | |
| 10-2404AUS | In distribution | |
| 10-3442AUS | In distribution | |
| 12-1445AUS | In distribution | |
| 10-2604NS | Length 7.5 in | In distribution |
| 95-6230 | Length 10 in | In distribution |
| 20-1615NS | Length 7.13 in | In distribution |
| 10-3415AUS | In distribution | |
| 12-1045S | In distribution | |
| 20-1010 | Length 6.25 in | In distribution |
| 28-2000E | In distribution | |
| 10-3402AUS | In distribution | |
| 20-1620AUS | In distribution | |
| 12-1237NSS | In distribution | |
| 12-1635AUS | In distribution | |
| 22-1653PL | In distribution | |
| 19-5044AU | In distribution | |
| 12-1436AUS | In distribution | |
| 10-2100AUS | In distribution | |
| 20-1420AUS | In distribution | |
| 21-1429AUS | In distribution | |
| 10-2402AUS | In distribution | |
| 24-1459AUS | In distribution | |
| 19-2022AUX | Length 7 in | In distribution |
| 14-9002 | Length 5.5 in | In distribution |
| 21-1410EAU | Length 7 in | In distribution |
| 28-2000W | In distribution | |
| 24-1427AU | Length 6.25 in | In distribution |
| 21-1429AUS | In distribution | |
| 19-1236AUX | Length 10 in | In distribution |
| 12-1400AUS | In distribution | |
| 12-1400AUS | Length 8 in | In distribution |
| 10-6000 | Length 12 ft | In distribution |
| 21-1421AUS | In distribution | |
| 11-50202 | Length 12 ft | In distribution |
| 19-2034AU | Length 8 in | In distribution |
| 12-1633AUS | Length 8.5 in | In distribution |
| 24-1444AU | Length 8 in | In distribution |
| 12-1633AUS | In distribution | |
| 19-1231AUX | Length 8.5 in | In distribution |
| 14-7008 | Length 5 in | In distribution |
| 10-3402AUS | In distribution | |
| 19-1227AUX | Length 8.5 in | In distribution |
| 12-1438AUS | Length 9.5 in | In distribution |
| 19-1229AU | Length 8.5 in | In distribution |
| 20-1617AUS | In distribution | |
| 23-1451AUS | In distribution | |
| 10-2002 | Length 7 in | In distribution |
| 10-2404AUS | In distribution | |
| 12-1434AUS | In distribution | |
| 10-5601NSS | In distribution | |
| 12-1436AUS | In distribution | |
| 24-1444EAU | Length 8 in | In distribution |
| 10-5402AU | Length 8.75 in | In distribution |
| 18-3010 | Length 4.75 in | In distribution |
| 20-1614AU | Length 7.13 in | In distribution |
| 20-1118AU | Length 7.88 in | In distribution |
| 21-1425AUS | In distribution | |
| 19-1229IR | Length 8.5 in | In distribution |
| 14-5011S | In distribution | |
| 22-1665PL | In distribution | |
| 15-3110 | Length 4.5 in | In distribution |
| 14-7000AL | Length 4.38 in | In distribution |
| 24-1445AUS | In distribution | |
| 20-1419NSS | Length 8.5 in | In distribution |
| 12-1438AUSX | In distribution | |
| 19-2046AUX | Length 9 in | In distribution |
| 20-1410AUS | In distribution | |
| 19-5024AUIR | In distribution | |
| 12-1438AUS | In distribution | |
| 12-1400AUS | In distribution | |
| 20-1217NS | Length 7.13 in | In distribution |
| 10-1603AUS | In distribution | |
| 10-1634AU | Length 7.75 in | In distribution |
| 24-1444AUS | In distribution | |
| 20-1620AUS | In distribution | |
| 28-2000-36 | In distribution | |
| 12-1600AUS | In distribution | |
| 20-1630AU | Length 7.88 in | In distribution |
| 12-1445AUS | In distribution | |
| 24-1468AUS | In distribution | |
| 10-5401EAU | Length 8.75 in | In distribution |
| 10-1403AUS | Length 10 in | In distribution |
| 10-5402NS | Length 8.75 in | In distribution |
| 12-1085AL | Length 3.38 in | In distribution |
| 19-1236AU | Length 10 in | In distribution |
| 12-1432AUS | In distribution | |
| 10-3415AUS | In distribution | |
| 10-2100AUS | In distribution | |
| 12-1435EAU | Length 8.63 in | In distribution |
| 10-5604AUS | In distribution | |
| 24-1435AUS | In distribution | |
| 15-2404AU | Length 7.5 in | In distribution |
| 10-6050S | Length 5 m | In distribution |
| 20-1618AUS | In distribution | |
| 22-1662PL | In distribution | |
| 21-1429AUS | In distribution | |
| 22-1443PL | Length 8 in | In distribution |
| 12-1040 | Length 5.5 in | In distribution |
| 21-1406AU | Length 6 in | In distribution |
| 20-1610AUS | In distribution | |
| 19-1235CX | Length 10 in | In distribution |
| 12-1633AUS | In distribution | |
| 18241-M861 | Length 4 in | In distribution |
| 11-1403AUS | In distribution | |
| 24-1447AUS | In distribution | |
| 24-1468AUS | In distribution | |
| 19-5034AU | In distribution | |
| 20-1214NS | Length 7.13 in | In distribution |
| 21-1415AU | Length 7.75 in | In distribution |
| 12-1436AUS | In distribution | |
| 10-3202NS | Length 4 in | In distribution |
| 20-1610AUS | In distribution | |
| 20-1410AUS | In distribution | |
| 20-1414AUS | In distribution | |
| 12-1637AUS | Length 9.5 in | In distribution |
| 12-1400AUS | Length 9 in | In distribution |
| 15-5303 | Length 8.75 in | In distribution |
| 23-1421AUS | In distribution | |
| 21-1406AUS | Length 14 cm | In distribution |
| 19-2002CX | Length 7 in | In distribution |
| 22-1453PL | Length 8.75 in | In distribution |
| 23-1415AUS | In distribution | |
| 10-5404NSS | Length 11.25 in | In distribution |
| 12-5100AUS | In distribution | |
| 19-5034AUIR | In distribution | |
| 19-2002AU | Length 7 in | In distribution |
| 21-1416AUS | In distribution | |
| 19-2000AU | Length 6 in | In distribution |
| 12-5104AU | Length 9.5 in | In distribution |
| 20-1317 | Length 7.13 in | In distribution |
| 21-1427AUS | In distribution | |
| 21-1427AUS | In distribution | |
| 10-2200NSS | In distribution | |
| 12-5108AU | Length 10.5 in | In distribution |
| 12-1633AUS | In distribution | |
| 20-1411AUS | In distribution | |
| 10-5404EAUS | In distribution | |
| 23-1413AUS | In distribution | |
| 19-2026AUX | Length 7 in | In distribution |
| 23-1432AUS | In distribution | |
| 11-1603AUS | In distribution | |
| 20-1217NSS | In distribution | |
| 10-5404NS | Length 8.75 in | In distribution |
| 19-1200 | Length 7.5 in | In distribution |
| 10-1603AUS | In distribution | |
| 15-5303S | In distribution | |
| 10-5601NSS | Length 10 in | In distribution |
| 20-1113AU | Length 6.25 in | In distribution |
| 15-1433AU | Length 8.5 in | In distribution |
| 10-2100AUS | In distribution | |
| 19-1251C | Length 8 in | In distribution |
| 12-1237NSS | In distribution | |
| 18241-M978 | In distribution | |
| 21-1424AUS | In distribution | |
| 18241-0976 | In distribution | |
| 10-6000VS | In distribution | |
| 21-1427AUS | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Novo Surgical | Novo Surgical, Inc. | 510 |
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 Naming This Product
7 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Kirwan Surgical Products, LLC. | 510(k) number | 2024-11-14 | Class I | Device Design | Potential for the outer stainless-steel tube to break or detach. | 80,060 units |
| Kirwan Surgical Products, LLC. | 510(k) number | 2024-11-14 | Class I | Device Design | Potential for the outer stainless-steel tube to break or detach. | 66 units |
| Kirwan Surgical Products, LLC. | 510(k) number | 2024-11-14 | Class I | Device Design | Potential for the outer stainless-steel tube to break or detach. | 800 units |
| Kirwan Surgical Products, LLC. | 510(k) number | 2024-11-14 | Class I | Device Design | Potential for the outer stainless-steel tube to break or detach. | 4,470 units |
| Kirwan Surgical Products, LLC. | 510(k) number | 2024-11-14 | Class I | Device Design | Potential for the outer stainless-steel tube to break or detach. | 3,010 units |
| Kirwan Surgical Products, LLC. | 510(k) number | 2024-11-14 | Class I | Device Design | Potential for the outer stainless-steel tube to break or detach. | 925 units |
| Kirwan Surgical Products, LLC. | 510(k) number | 2024-11-14 | Class I | Device Design | Potential for the outer stainless-steel tube to break or detach. | 2,999 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.