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…

Registry build 21.09.26

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

65manufacturers in China registered for this device type
756catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code GEI
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

Regulatory record for Ambler Surgical
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

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 numbers for Ambler Surgical
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

Other products under the same FDA 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.

Recalls naming the identifiers of Ambler Surgical
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer