AED
Speedlock Retraction Forcep With Atraumatic Inner Teeth, 5MM With Ratchet Handle: 8511-01 Standard Composite, 34CM Length
65manufacturers in China registered for this device type
115catalogue 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 |
| 510(k) | K081553 |
| Record published | 2019-05-07 |
| Record revised | 2019-08-21 (version 5) |
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, manufacturing date, serial number |
| Distribution end date | 2025-08-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A1461 | In distribution | |
| AED116703 | In distribution | |
| AED 33310UL-R | In distribution | |
| SP1600 | In distribution | |
| BP-CBL | In distribution | |
| 11-1260KA | In distribution | |
| A1318 | In distribution | |
| 1362 | In distribution | |
| 13-1634iWO | In distribution | |
| 13-1599-A-I | In distribution | |
| AED 33321AF | In distribution | |
| AED 33321C | In distribution | |
| P-MDF100-I | In distribution | |
| 33156-AED | In distribution | |
| STA1593 | In distribution | |
| STA1592 | In distribution | |
| D1368 | In distribution | |
| AED 33310CK | In distribution | |
| SPC5 | In distribution | |
| GT-8511-37 NM | In distribution | |
| XS1345-R | In distribution | |
| A1381-R | In distribution | |
| AED 33321DN | In distribution | |
| SNL230 | In distribution | |
| A1303-R | In distribution | |
| SPC12 | In distribution | |
| AED 33310MD-R | In distribution | |
| BP1641 | In distribution | |
| AED116850 | In distribution | |
| AED116800 | In distribution | |
| 33151-AED | In distribution | |
| 117650 | In distribution | |
| STZ1594-45 | In distribution | |
| 92323-R | In distribution | |
| AED 33310FG | In distribution | |
| A1375 | In distribution | |
| AED 33310R-R | In distribution | |
| 1358 | In distribution | |
| AED 33321DN-R | In distribution | |
| AED 33321CC | In distribution | |
| 111260BC-V | In distribution | |
| BP1632 | In distribution | |
| AED52005-61 | In distribution | |
| 8108.031 | In distribution | |
| AED KC-002 | In distribution | |
| AED 34321SL | In distribution | |
| SP1601 | In distribution | |
| 75-1358 | In distribution | |
| 16-1630ST | In distribution | |
| 22-2705 | In distribution | |
| A1431 | In distribution | |
| 111260BC-M | In distribution | |
| AED 33321AF-R | In distribution | |
| HW1260 | In distribution | |
| AED 33321C-R | In distribution | |
| 13-1641 | In distribution | |
| GT-PB560 NM | In distribution | |
| SPC10 | In distribution | |
| GT-8513-17 NM | In distribution | |
| 8393714-AED | In distribution | |
| AED 33310D | In distribution | |
| 13-JRT-45-R | In distribution | |
| GT-8512-09 NM | In distribution | |
| STA1594 | In distribution | |
| AED KC-2XL | In distribution | |
| STZ1593 | In distribution | |
| 30-1536 | In distribution | |
| A1375-R | In distribution | |
| 8512-09-I | In distribution | |
| AED 33310UL | In distribution | |
| LG100 | In distribution | |
| AED 33310FG-R | In distribution | |
| AED116732 | In distribution | |
| AED 33321A-R | In distribution | |
| STZ1593-45 | In distribution | |
| AED 33310CK-R | In distribution | |
| 22-2715 | In distribution | |
| AED 33300 | In distribution | |
| GT-PB500 NM | In distribution | |
| 91565-D-I | In distribution | |
| BC1175 | In distribution | |
| STZ1594 | In distribution | |
| 75-0130 | In distribution | |
| STZ1592 | In distribution | |
| AED 33321CC-R | In distribution | |
| 111260BC-E | In distribution | |
| 8108.034 | In distribution | |
| 8517A | In distribution | |
| BP1631 | In distribution | |
| AED 33310P | In distribution | |
| AED116800 | In distribution | |
| AED 34310MA | In distribution | |
| A1346 | In distribution | |
| AED 33310R | In distribution | |
| XPW1592 | In distribution | |
| AED 33310D-R | In distribution | |
| 13-1635iWo | In distribution | |
| A1460 | In distribution | |
| 8512-37-R/8511-01 | In distribution | |
| AED 33310FM | In distribution | |
| XS1620 | In distribution | |
| AED 33310FM-R | In distribution | |
| 13-1360iW | In distribution | |
| STZ1592-45 | In distribution | |
| MO5000 | In distribution | |
| AED 33310MD | In distribution | |
| A1354 | In distribution | |
| BP1700 | In distribution | |
| 13-1646SI | In distribution | |
| AED 33321A | In distribution | |
| 1366 | In distribution | |
| SNL100 | In distribution | |
| 8517-09 | In distribution | |
| A1381-R | Withdrawn | |
| W1594 | Withdrawn |
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 |
|---|---|
| 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.