Speedlock
Speedlock Wave Grasper DG, 5mm with Atraumatic Wave-like Serrations, Single Action with Ratchet Handle: 8510-02 Composite French Style, 34cm Length
65manufacturers in China registered for this device type
5,212catalogue numbers in this listing
2510(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.
| 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 | National Advanced Endoscopy Devices, Inc., United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-12-16 |
| Record revised | 2019-08-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2019-02-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8513-05-26-R/8510-02 | In distribution | |
| 8515-21-26/1358 | In distribution | |
| 8512-45-45-R | In distribution | |
| 8514-85-R/D1368 | In distribution | |
| 8512-41-R/8510-02 | In distribution | |
| 8514-33-30-R/1362 | In distribution | |
| 8512-65-45-R/1362 | In distribution | |
| 8510-41-30/8510-00 | In distribution | |
| 8512-05-45/1366 | In distribution | |
| 8513-11-26/1358 | In distribution | |
| 8512-61/8510-00 | In distribution | |
| 8513-03/8511-02 | In distribution | |
| 8513-05-45-R/8510-01 | In distribution | |
| 8514-11-30-R/1362 | In distribution | |
| 8517-10-26-R/8510-02 | In distribution | |
| 8510-21-45-R/8510-02 | In distribution | |
| 8511-07-45-R/D1368 | In distribution | |
| 8511-36-26-R/8511-01 | In distribution | |
| 8514-41-R/D1368 | In distribution | |
| 8512-33-30/8510-00 | In distribution | |
| 8511-07-45-R/8511-01 | In distribution | |
| 8512-53-30/8511-02 | In distribution | |
| 8515-45-26-R/8510-02 | In distribution | |
| 8515-05-26-R/D1368 | In distribution | |
| 8515-05-26-R/1358 | In distribution | |
| 8510-13-26/1366 | In distribution | |
| 8511-07-R/1358 | In distribution | |
| 8510-25-45-R/1358 | In distribution | |
| 8512-29-R/1358 | In distribution | |
| 8514-05-45/1366 | In distribution | |
| 8514-85-R/1362 | In distribution | |
| 8514-93-R/8510-01 | In distribution | |
| 8517-10-30-R/1358 | In distribution | |
| 8510-25-I | In distribution | |
| 8512-13-26/1366 | In distribution | |
| 8514-13/1366 | In distribution | |
| 8514-95-26-R/8511-00 | In distribution | |
| 8511-03-45-R/8511-00 | In distribution | |
| 8510-05-45-R/8511-01 | In distribution | |
| 8512-49-45/1366 | In distribution | |
| 8513-03-45/8511-02 | In distribution | |
| 8512-53-30-R/1362 | In distribution | |
| 8513-05-26/8510-00 | In distribution | |
| 8512-05/8511-02 | In distribution | |
| 8514-15-45-R | In distribution | |
| 8511-41-45/1358 | In distribution | |
| 8512-09-45/1366 | In distribution | |
| 8514-85-45-R/8510-02 | In distribution | |
| 8616-00-45-R/1362 | In distribution | |
| 8511-21-26-R/8511-01 | In distribution | |
| 8511-37-30/1358 | In distribution | |
| 8512-41-R/1358 | In distribution | |
| 8515-41-45-R/1362 | In distribution | |
| 8514-45-30-R/8510-01 | In distribution | |
| 8514-53-30-R/8510-02 | In distribution | |
| 8510-57-45/1366 | In distribution | |
| 8514-15-45-R/8511-01 | In distribution | |
| 8513-25-30/8510-00 | In distribution | |
| 8510-29-R/1358 | In distribution | |
| 8511-33-26-R/1362 | In distribution | |
| 8514-05-26/8510-00 | In distribution | |
| 8514-61-30/1358 | In distribution | |
| 8517-04-R/8511-00 | In distribution | |
| 8514-15-26-R | In distribution | |
| 8510-03-45/8510-00 | In distribution | |
| 8511-07-R/1362 | In distribution | |
| 8512-45-30-R/1362 | In distribution | |
| 8515-45-26-R/D1368 | In distribution | |
| 8510-21-26 | In distribution | |
| 8511-07-30/8510-00 | In distribution | |
| 8512-53/1358 | In distribution | |
| 8512-65/1366 | In distribution | |
| 8514-61-45-R/D1368 | In distribution | |
| 8513-19/1366 | In distribution | |
| 8514-11-R/8510-02 | In distribution | |
| 8510-46-30-R/1358 | In distribution | |
| 8514-81-45-R/1358 | In distribution | |
| 8517-10-30/1366 | In distribution | |
| 8515-33-45-R/1362 | In distribution | |
| 8512-29-30/1366 | In distribution | |
| 8513-07-26/8511-02 | In distribution | |
| 8514-49/1366 | In distribution | |
| 8514-81-26/1358 | In distribution | |
| 8514-15-26/1358 | In distribution | |
| 8512-25-R/1362 | In distribution | |
| 8512-17-R/8510-02 | In distribution | |
| 8514-09-30-R/1358 | In distribution | |
| 8510-61-45-R | In distribution | |
| 8514-09-30-R/8511-01 | In distribution | |
| 8510-03-45-R/1362 | In distribution | |
| 8512-65-30-R/D1368 | In distribution | |
| 8510-46-26-R/8510-02 | In distribution | |
| 8511-37-R/8511-01 | In distribution | |
| 8514-01-R/1362 | In distribution | |
| 8514-09-R/8510-01 | In distribution | |
| 8514-81/1358 | In distribution | |
| 8516-00-30/8510-00 | In distribution | |
| 8516-08-R/8510-01 | In distribution | |
| 8517-06-30-R/D1368 | In distribution | |
| 8511-15-45-R/1358 | In distribution | |
| 8514-65-R/8510-01 | In distribution | |
| 8512-41-45-R/8510-02 | In distribution | |
| 8515-41-45/1366 | In distribution | |
| 8515-21-45-R/8510-01 | In distribution | |
| 8513-17-I | In distribution | |
| 8510-37-30-R/8511-01 | In distribution | |
| 8512-29-26-R/1358 | In distribution | |
| 8512-25-R/8510-02 | In distribution | |
| 8512-61/1366 | In distribution | |
| 8513-03/8510-00 | In distribution | |
| 8514-11-30-R/1358 | In distribution | |
| 8517-02-26-R/1358 | In distribution | |
| 8516-12-R | In distribution | |
| 8510-03-26-R | In distribution | |
| 8514-81-I | In distribution | |
| 8515-29-30-R/8511-00 | In distribution | |
| 8515-13-45 | In distribution | |
| 8513-21/1366 | In distribution | |
| 8514-33-30/1366 | In distribution | |
| 8511-25-33-I | In distribution | |
| 8511-17-45-R/8511-00 | In distribution | |
| 8514-37-R/8510-01 | In distribution | |
| 8515-25-R/1358 | In distribution | |
| 8511-05-45/8510-00 | In distribution | |
| 8512-45-R/8510-01 | In distribution | |
| 8510-37-R/8510-01 | In distribution | |
| 8515-17-30/1358 | In distribution | |
| 8510-05-26-R/D1368 | In distribution | |
| 8511-09-30-R/1362 | In distribution | |
| 8512-41-R/8511-00 | In distribution | |
| 8515-25-26-R | In distribution | |
| 8513-17-45/8511-02 | In distribution | |
| 8516-08-R/8511-01 | In distribution | |
| 8517-02-45/1366 | In distribution | |
| 8511-05-26/8510-00 | In distribution | |
| 8512-09/1358 | In distribution | |
| 8510-46/8510-00 | In distribution | |
| 8512-32-45-R/1358 | In distribution | |
| 8514-89-26-R/D1368 | In distribution | |
| 8515-41-30-R/8510-02 | In distribution | |
| 8513-03-45-I | In distribution | |
| 8512-09-R/1358 | In distribution | |
| 8512-33-26-R/8510-02 | In distribution | |
| 8514-61-R/8511-00 | In distribution | |
| 8511-03-45 | In distribution | |
| 8510-57-45 | In distribution | |
| 8511-41/8510-00 | In distribution | |
| 8514-53-26/8510-00 | In distribution | |
| 8511-25-26/1366 | In distribution | |
| 8514-01-30-R/8510-02 | In distribution | |
| 8512-33 | In distribution | |
| 8515-33/1366 | In distribution | |
| 8513-03-26/8510-00 | In distribution | |
| 8514-01-45/1358 | In distribution | |
| 8514-53-45-R/1358 | In distribution | |
| 8515-13-30-R/1358 | In distribution | |
| 8510-41 | In distribution | |
| 8510-03/8510-00 | In distribution | |
| 8514-01-I | In distribution | |
| 8514-49-30-R/8511-01 | In distribution | |
| 8510-41-30-R/D1368 | In distribution | |
| 8514-61/8511-02 | In distribution | |
| 8510-53-R | In distribution | |
| 8514-69-45 | In distribution | |
| 8515-33-45-R/8511-00 | In distribution | |
| 8517-08-R/8510-01 | In distribution | |
| 8510-61-I | In distribution | |
| 8510-57-R/8511-00 | In distribution | |
| 8511-17-30-R/1358 | In distribution | |
| 8510-05/8510-00 | In distribution | |
| 8514-81-R/8511-00 | In distribution | |
| 8510-46-26-R/8510-01 | In distribution | |
| 8512-16-45-R/D1368 | In distribution | |
| 8512-25-30-R/1358 | In distribution | |
| 8511-37/8511-02 | In distribution | |
| 8512-61-45/8510-00 | In distribution | |
| 8514-41-26/8511-02 | In distribution | |
| 8616-00-45-R/8510-01 | In distribution | |
| 8512-13-30/1366 | In distribution | |
| 8514-13-26-R/8511-00 | In distribution | |
| 8512-13-45-R | In distribution | |
| 8510-49-45 | In distribution | |
| 8514-05-45/1358 | In distribution | |
| 8517-02-30/1366 | In distribution | |
| 8514-41-30-R/D1368 | In distribution | |
| 8515-33-R/1358 | In distribution | |
| 8514-05-R/8510-02 | In distribution | |
| 8514-25-R | In distribution | |
| 8515-17-R/D1368 | In distribution | |
| 8511-03-26-R/8511-00 | In distribution | |
| 8511-29-30/1366 | In distribution | |
| 8512-05-30/8511-02 | In distribution | |
| 8514-85 | In distribution | |
| 8512-09-45/8510-00 | In distribution | |
| 8510-53 | In distribution | |
| 8512-13-I | In distribution | |
| 8516-08-I | In distribution | |
| 8514-71-60-R/D1368 | In distribution | |
| 8515-33-30/8511-02 | In distribution | |
| 8511-33-30/8510-00 | In distribution | |
| 8515-37-45-R/8510-02 | In distribution | |
| 8511-17-C | In distribution | |
| 8510-53-26/8511-02 | In distribution | |
| 8514-85-45-I | In distribution | |
| 8510-25-45-R/D1368 | In distribution | |
| 8510-41-R/1362 | In distribution | |
| 8511-25/1366 | In distribution | |
| 8512-09-26/1358 | In distribution | |
| 8512-16-26-R/8511-00 | In distribution | |
| 8514-15/1366 | In distribution | |
| 8514-61-26-R/1358 | In distribution | |
| 8514-95-45/1358 | In distribution | |
| 8517-00/8511-02 | In distribution | |
| 8518-00-26/8510-00 | In distribution | |
| 8517-02-45/1358 | In distribution | |
| 8517-10-45/8510-00 | In distribution | |
| 8516-00-R/1362 | In distribution | |
| 8517-08-I | In distribution | |
| 8510-21/8510-00 | In distribution | |
| 8510-53-26/8510-00 | In distribution | |
| 8515-45-45-R/1358 | In distribution | |
| 8516-08-30/1358 | In distribution | |
| 8518-00-26-R/8511-00 | In distribution | |
| 8514-29-R/8511-01 | In distribution | |
| 8514-85-R | In distribution | |
| 8510-13-30/1366 | In distribution | |
| 8510-09-R/1362 | In distribution | |
| 8512-09-26-R/1358 | In distribution | |
| 8514-93-30/1358 | In distribution | |
| 8515-13-R/8510-01 | In distribution | |
| 8511-41-45-R/8511-01 | In distribution | |
| 8514-81-45-R/8511-00 | In distribution | |
| 8517-08-30/1358 | In distribution | |
| 8511-15-R/8511-01 | In distribution | |
| 8515-01 | In distribution | |
| 8515-21-45-R/8510-02 | In distribution | |
| 8510-57-30-R/8511-01 | In distribution | |
| 8515-17/1366 | In distribution | |
| 8514-85-45/8511-02 | In distribution | |
| 8517-06-26-R/1362 | In distribution | |
| 8514-29-30/1358 | In distribution | |
| 8514-81-45 | In distribution | |
| 8511-09-30/1366 | In distribution | |
| 8512-45-R/8511-01 | In distribution | |
| 13-1599A-45-R/1362 | In distribution | |
| 8510-03-30-R/1362 | In distribution | |
| 8510-25-30-R/8511-00 | In distribution | |
| 8511-21-45-R/8510-01 | In distribution | |
| 8512-65-26-R/D1368 | In distribution | |
| 8514-29/1358 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 5,729 |
| 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 |
| Novo Surgical | Novo Surgical, Inc. | 510 |
Showing 12 of 2,922. All products under Electrosurgical, Cutting & Coagulation & Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K081553 | 2008-09-29 |
| K081503 | 2008-09-25 |
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.