Ambler Surgical
Allis atraumatic grasping forceps, non-rotatable, double-action, 5.0mm diameter, 350.0mm working length, insulated shaft, straight tips, fine serrated jaws, interlocking teeth, ring handle…
Allis atraumatic grasping forceps, non-rotatable, double-action, 5.0mm diameter, 350.0mm working length, insulated shaft, straight tips, fine serrated jaws, interlocking teeth, ring handle with ratchet catch
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 | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Repacker / relabeller |
| 510(k) | K123478 |
| Record published | 2021-01-04 |
| Record revised | 2018-07-06 (version 4) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10, box of 5, box of 3 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Kleppinger bipolar forceps | In distribution | |
| PR7426 | In distribution | |
| 31-498 | In distribution | |
| 25-886 | In distribution | |
| 25-370 | In distribution | |
| PR7410 | In distribution | |
| 25-486 | In distribution | |
| 31-476 | In distribution | |
| Fundus dual cup grasping forceps | In distribution | |
| Grasping forceps | In distribution | |
| 26-020 | In distribution | |
| Bipolar pencil | In distribution | |
| 25-366 | In distribution | |
| 26-598 | In distribution | |
| 25-787-U45 | In distribution | |
| 26-618 | In distribution | |
| 25-785-U45 | In distribution | |
| 25-773 | In distribution | |
| 25-781-D45 | In distribution | |
| 26-644 | In distribution | |
| 25-272 | In distribution | |
| 25-930 | In distribution | |
| 31-738 | In distribution | |
| 2079E | In distribution | |
| Babcock grasping forceps | In distribution | |
| 25-628 | In distribution | |
| Metzenbaum scissors | In distribution | |
| 25-812 | In distribution | |
| Allis grasping forceps | In distribution | |
| 25-468 | In distribution | |
| 25-775-D45 | In distribution | |
| 25-482 | In distribution | |
| DeBakey forceps | In distribution | |
| 25-996 | In distribution | |
| 25-760 | In distribution | |
| 26-558 | In distribution | |
| DeBakey grasping forceps | In distribution | |
| 26-026 | In distribution | |
| 25-972 | In distribution | |
| 25-678 | In distribution | |
| 25-776-D45 | In distribution | |
| 26-262 | In distribution | |
| Hook scissors | In distribution | |
| 25-624 | In distribution | |
| 25-041 | In distribution | |
| 25-773-D45 | In distribution | |
| 25-804 | In distribution | |
| 25-620 | In distribution | |
| Kleppinger bipolar forceps | In distribution | |
| 25-786 | In distribution | |
| PD7212 | In distribution | |
| Metzenbaum scissors | In distribution | |
| Strong grasping forceps | In distribution | |
| 2017E | In distribution | |
| 2042E | In distribution | |
| PR7412 | In distribution | |
| 25-490 | In distribution | |
| 25-740 | In distribution | |
| 25-734 | In distribution | |
| 25-982 | In distribution | |
| 25-705 | In distribution | |
| 26-260 | In distribution | |
| 25-770-U45 | In distribution | |
| 26-580 | In distribution | |
| 25-656 | In distribution | |
| 25-380 | In distribution | |
| 25-980 | In distribution | |
| 2039E | In distribution | |
| 25-320-U45 | In distribution | |
| Fundus dual cup grasping forceps | In distribution | |
| Puncture needle with irrigation | In distribution | |
| 26-668 | In distribution | |
| Peritoneal scissors | In distribution | |
| 25-433 | In distribution | |
| 25-738 | In distribution | |
| Cushing bipolar forceps | In distribution | |
| 25-792-U45 | In distribution | |
| Claw grasping forceps | In distribution | |
| 25-890 | In distribution | |
| 31-484 | In distribution | |
| 25-720 | In distribution | |
| 25-065 | In distribution | |
| 25-050 | In distribution | |
| 25-429 | In distribution | |
| BC-103 | In distribution | |
| 25-878 | In distribution | |
| 25-790-U45 | In distribution | |
| 25-464 | In distribution | |
| 25-594 | In distribution | |
| 25-874 | In distribution | |
| 25-712 | In distribution | |
| 26-018 | In distribution | |
| 25-423 | In distribution | |
| Metzenbaum scissors | In distribution | |
| 2026E | In distribution | |
| 25-864 | In distribution | |
| Cushing bipolar forceps | In distribution | |
| 25-758 | In distribution | |
| 25-427 | In distribution | |
| 25-775 | In distribution | |
| 26-034 | In distribution | |
| 26-060 | In distribution | |
| Yasargil bipolar forceps | In distribution | |
| 25-900 | In distribution | |
| Dolphin nose dissecting forceps | In distribution | |
| FD2026 | In distribution | |
| Hook scissors | In distribution | |
| 2021E | In distribution | |
| 25-942 | In distribution | |
| Metzenbaum scissors | In distribution | |
| Palpation probe | In distribution | |
| Peritoneal scissors | In distribution | |
| 25-956 | In distribution | |
| 26-660 | In distribution | |
| 26-008 | In distribution | |
| 25-376 | In distribution | |
| 25-988 | In distribution | |
| Allis atraumatic grasping forceps | In distribution | |
| 25-802 | In distribution | |
| Micro scissors | In distribution | |
| 26-530 | In distribution | |
| Metzenbaum scissors | In distribution | |
| 25-020 | In distribution | |
| Micro scissors | In distribution | |
| 25-968 | In distribution | |
| 25-338 | In distribution | |
| 25-364 | In distribution | |
| 25-431 | In distribution | |
| Tenaculum grasping forceps | In distribution | |
| 2037E | In distribution | |
| 2032E | In distribution | |
| 25-798 | In distribution | |
| 26-614 | In distribution | |
| Metzenbaum scissors | In distribution | |
| 25-954 | In distribution | |
| 26-044 | In distribution | |
| 25-040 | In distribution | |
| 25-796-U45 | In distribution | |
| Metzenbaum scissors | In distribution | |
| 25-898 | In distribution | |
| Fan retractor | In distribution | |
| 26-594 | In distribution | |
| Fundus wave grasping forceps | In distribution | |
| Mixter dissecting forceps | In distribution | |
| 25-476 | In distribution | |
| 25-950 | In distribution | |
| 26-250 | In distribution | |
| 25-590 | In distribution | |
| 25-902 | In distribution | |
| 26-552 | In distribution | |
| 25-793-U45 | In distribution | |
| Bowel grasping forceps | In distribution | |
| 25-250 | In distribution | |
| Maryland dissecting forceps | In distribution | |
| 2048E | In distribution | |
| 26-646 | In distribution | |
| Bowel grasping forceps | In distribution | |
| 25-936 | In distribution | |
| Metzenbaum scissors | In distribution | |
| Allis atraumatic grasping forceps | In distribution | |
| 2044E | In distribution | |
| Scoville-Greenwood bipolar forceps | In distribution | |
| Hook scissors | In distribution | |
| 25-362 | In distribution | |
| DeBakey grasping forceps | In distribution | |
| Puncture needle with irrigation | In distribution | |
| 25-772 | In distribution | |
| 26-014 | In distribution | |
| 25-736 | In distribution | |
| 26-544 | In distribution | |
| 25-948 | In distribution | |
| 26-002 | In distribution | |
| 25-854 | In distribution | |
| 25-998 | In distribution | |
| 25-852 | In distribution | |
| 25-732 | In distribution | |
| MicroGlide MIS bipolar forceps | In distribution | |
| 25-660 | In distribution | |
| 31-734 | In distribution | |
| Micro scissors | In distribution | |
| 26-022 | In distribution | |
| 25-783-D45 | In distribution | |
| 25-795 | In distribution | |
| 26-040 | In distribution | |
| 25-060 | In distribution | |
| 25-848 | In distribution | |
| 26-666 | In distribution | |
| 26-652 | In distribution | |
| 25-783 | In distribution | |
| Yasargil bipolar forceps | In distribution | |
| MicroGlide MIS bipolar forceps | In distribution | |
| 25-718 | In distribution | |
| 25-664 | In distribution | |
| 26-090 | In distribution | |
| 25-630 | In distribution | |
| Babcock grasping forceps | In distribution | |
| 25-336 | In distribution | |
| 26-088 | In distribution | |
| 25-439 | In distribution | |
| 26-538 | In distribution | |
| 25-390 | In distribution | |
| 25-771 | In distribution | |
| 25-922 | In distribution | |
| 25-770 | In distribution | |
| 25-772-U45 | In distribution | |
| 25-654 | In distribution | |
| Metzenbaum scissors | In distribution | |
| Metzenbaum scissors | In distribution | |
| 25-706 | In distribution | |
| 26-610 | In distribution | |
| 25-780-D45 | In distribution | |
| Strong grasping forceps | In distribution | |
| 25-924 | In distribution | |
| 25-284 | In distribution | |
| MicroGlide MIS bipolar forceps | In distribution | |
| 26-526 | In distribution | |
| 25-798-U45 | In distribution | |
| 25-318 | In distribution | |
| 25-425 | In distribution | |
| 26-562 | In distribution | |
| Grasping forceps | In distribution | |
| 25-450 | In distribution | |
| Hook scissors | In distribution | |
| 25-844 | In distribution | |
| 25-795-U45 | In distribution | |
| Kleppinger bipolar forceps | In distribution | |
| 26-070 | In distribution | |
| Jeweler’s-type bipolar forceps | In distribution | |
| 25-435 | In distribution | |
| 25-730 | In distribution | |
| 26-662 | In distribution | |
| 26-076 | In distribution | |
| 26-554 | In distribution | |
| 2047E | In distribution | |
| 25-452 | In distribution | |
| 25-796-D45 | In distribution | |
| 2043E | In distribution | |
| 25-456 | In distribution | |
| 26-522 | In distribution | |
| 25-349 | In distribution | |
| 25-466 | In distribution | |
| 25-622 | In distribution | |
| 26-012 | In distribution | |
| 26-066 | In distribution | |
| 25-312 | In distribution | |
| 26-000 | In distribution | |
| 25-782-D45 | In distribution | |
| Metzenbaum scissors | In distribution | |
| Yasargil bipolar forceps | In distribution | |
| MicroGlide MIS bipolar forceps | 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 |
| 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 |
| 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
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.