Sutter
Connection cable for patient plate 4.5m, for single use patient plate for Sutter BM-780 II, Martin, Aesculap
65manufacturers in China registered for this device type
312catalogue numbers in this listing
9510(k) clearances naming this product code
1recall
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 | Sutter Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2019-11-12 |
| Record revised | 2023-04-04 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Packaging | Carton of 20, carton of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 364472 | In distribution | |
| 7844905ST | In distribution | |
| 780449SGS | In distribution | |
| 700955S | In distribution | |
| 780198SLS | In distribution | |
| 700919SGS | In distribution | |
| 360112 | In distribution | |
| 783196SGS | In distribution | |
| 370153R | In distribution | |
| 780281SGS | In distribution | |
| 783051SGS | In distribution | |
| 370150W | In distribution | |
| 700916S | In distribution | |
| 700951S | In distribution | |
| 370138P | In distribution | |
| 370154R | In distribution | |
| 782387SLS | In distribution | |
| AR-S9805-010-J | In distribution | |
| 364475 | In distribution | |
| 360173-30 | In distribution | |
| 360171 | In distribution | |
| 784960SGSZ | In distribution | |
| 780381SGS | In distribution | |
| 780599SGS | In distribution | |
| AR-S9800-F2 | In distribution | |
| 364428 | In distribution | |
| 700957SGS | In distribution | |
| 700953SGS | In distribution | |
| 7844410SL | In distribution | |
| 780395SGS | In distribution | |
| 780148SGS | In distribution | |
| 370138G | In distribution | |
| 370130P | In distribution | |
| 700994S | In distribution | |
| 360191 | In distribution | |
| 700918SGS | In distribution | |
| 780169SLS | In distribution | |
| 7844405ST | In distribution | |
| 7844115SL | In distribution | |
| 370135K | In distribution | |
| 784990SGSZ | In distribution | |
| 782151SGS | In distribution | |
| 360100-05 | In distribution | |
| 704495 | In distribution | |
| 700967S | In distribution | |
| 700949 | In distribution | |
| 364442 | In distribution | |
| 780299SGS | In distribution | |
| 780178SGS | In distribution | |
| 784950SGSZ | In distribution | |
| 370138K | In distribution | |
| 700969SGS | In distribution | |
| 360100-01 | In distribution | |
| 700988S | In distribution | |
| 782182SGS | In distribution | |
| 782585SLS | In distribution | |
| 7844710ST | In distribution | |
| 780295SGS | In distribution | |
| 782158SGS | In distribution | |
| 700908S | In distribution | |
| 780198SGS | In distribution | |
| 780171SGS | In distribution | |
| 700984S | In distribution | |
| 780168SGS | In distribution | |
| 783253SGS | In distribution | |
| 782183SGS | In distribution | |
| 700909S | In distribution | |
| AR-S9805-0028 | In distribution | |
| 780191SGS | In distribution | |
| 782180SGS | In distribution | |
| 780298SGS | In distribution | |
| 782287SLS | In distribution | |
| 370154P | In distribution | |
| 783052SGS | In distribution | |
| 784996SGSZ | In distribution | |
| 780190SGS | In distribution | |
| 370138R | In distribution | |
| 782189SGS | In distribution | |
| 7844415ST | In distribution | |
| 370138S | In distribution | |
| 370150A | In distribution | |
| 780197SGS | In distribution | |
| 780194SGS | In distribution | |
| 780275SGS | In distribution | |
| 700920SGS | In distribution | |
| 780167SLS | In distribution | |
| 782285SGS | In distribution | |
| 782181SLS | In distribution | |
| 7844405STI | In distribution | |
| 700958S | In distribution | |
| 780154SGS | In distribution | |
| 700986S | In distribution | |
| 7844405SL | In distribution | |
| 784977SGSZ | In distribution | |
| 780199SLS | In distribution | |
| 784957SGSZ | In distribution | |
| AR-S9800 | In distribution | |
| 364474 | In distribution | |
| 360110 | In distribution | |
| 370150K | In distribution | |
| 700959S | In distribution | |
| 370150P | In distribution | |
| 7844910ST | In distribution | |
| 364420 | In distribution | |
| 780391SGS | In distribution | |
| 370150R | In distribution | |
| 780469SLS | In distribution | |
| 780192SGS | In distribution | |
| 370150VS | In distribution | |
| 783191SGS | In distribution | |
| 782397SLS | In distribution | |
| 370154G | In distribution | |
| 370140SG | In distribution | |
| 7844415STI | In distribution | |
| 780437SGS | In distribution | |
| 783197SGS | In distribution | |
| 360173-18 | In distribution | |
| 784987SGSZ | In distribution | |
| 7844410STI | In distribution | |
| 782396SLS | In distribution | |
| 360193 | In distribution | |
| 700919S | In distribution | |
| 700950S | In distribution | |
| 7844110SL | In distribution | |
| 780191SLS | In distribution | |
| 700910S | In distribution | |
| 700921S | In distribution | |
| 364421 | In distribution | |
| 7844105SL | In distribution | |
| 784954SGSZ | In distribution | |
| 780297SGS | In distribution | |
| 780176SGS | In distribution | |
| 370153A | In distribution | |
| 7844105STI | In distribution | |
| 360192 | In distribution | |
| 370130S | In distribution | |
| 700987S | In distribution | |
| 7844810ST | In distribution | |
| 780193SGS | In distribution | |
| 780237SGS | In distribution | |
| 780292SGS | In distribution | |
| 780454SGS | In distribution | |
| 782454SGS | In distribution | |
| 370130L | In distribution | |
| 370153SG | In distribution | |
| 700908SGS | In distribution | |
| 782386SLS | In distribution | |
| 780298SLS | In distribution | |
| 783276SGS | In distribution | |
| 360108 | In distribution | |
| 700918S | In distribution | |
| 360170 | In distribution | |
| 782154SGS | In distribution | |
| 360186 | In distribution | |
| 700942 | In distribution | |
| 360188 | In distribution | |
| 7844115ST | In distribution | |
| 370150SG | In distribution | |
| 700912SGS | In distribution | |
| 370130W | In distribution | |
| 700999SGS | In distribution | |
| 700940 | In distribution | |
| 784986SGSZ | In distribution | |
| 780157SGS | In distribution | |
| 780238SGS | In distribution | |
| 370135P | In distribution | |
| 784976SGSZ | In distribution | |
| 700920S | In distribution | |
| 364425 | In distribution | |
| 7844610ST | In distribution | |
| 780392SGS | In distribution | |
| 780195SGS | In distribution | |
| 370150G | In distribution | |
| 370138A | In distribution | |
| 780399SGS | In distribution | |
| 782189SLS | In distribution | |
| 360190 | In distribution | |
| 370135A | In distribution | |
| 700954S | In distribution | |
| 782297SLS | In distribution | |
| 364471 | In distribution | |
| 700917S | In distribution | |
| 7844115STI | In distribution | |
| 700967SGS | In distribution | |
| 360100-03 | In distribution | |
| 360236 | In distribution | |
| 784956SGSZ | In distribution | |
| 370135T | In distribution | |
| 370154A | In distribution | |
| 7844105ST | In distribution | |
| 780271SGS | In distribution | |
| 780599SLS | In distribution | |
| 784997SGSZ | In distribution | |
| 700951SGS | In distribution | |
| 360172 | In distribution | |
| 700958SGS | In distribution | |
| 783193SGS | In distribution | |
| 780243SGS | In distribution | |
| 780296SGS | In distribution | |
| 700969S | In distribution | |
| 364440 | In distribution | |
| 780239SGS | In distribution | |
| 780499SLS | In distribution | |
| AR-S9805-010-E | In distribution | |
| 370138T | In distribution | |
| 780294SGS | In distribution | |
| 370153G | In distribution | |
| 370138W | In distribution | |
| 780196SGS | In distribution | |
| 370130G | In distribution | |
| 7844415SL | In distribution | |
| 782181SGS | In distribution | |
| 780291SLS | In distribution | |
| 780175SGS | In distribution | |
| 360114 | In distribution | |
| 370130A | In distribution | |
| 780469SGS | In distribution | |
| 784966SGSZ | In distribution | |
| 7844110ST | In distribution | |
| 370154S | In distribution | |
| AR-S9800-F1 | In distribution | |
| 370150L | In distribution | |
| 700917SGS | In distribution | |
| 370138L | In distribution | |
| 780179SGS | In distribution | |
| 370153K | In distribution | |
| 784947SGSZ | In distribution | |
| 783195SGS | In distribution | |
| 370154L | In distribution | |
| 780291SGS | In distribution | |
| 370135W | In distribution | |
| 370150T | In distribution | |
| 700991S | In distribution | |
| 364410 | In distribution | |
| 700947 | In distribution | |
| 360107 | In distribution | |
| 700998SGS | In distribution | |
| 370153S | In distribution | |
| 783053SGS | In distribution | |
| 370140S | In distribution | |
| 780479SGS | In distribution | |
| 780167SGS | In distribution | |
| 782183SLS | In distribution | |
| 370130R | In distribution | |
| 370153P | In distribution | |
| AR-S9805-0035 | In distribution | |
| 700956S | In distribution | |
| 780499SGS | In distribution | |
| 780199SGS | In distribution | |
| 700907S | 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 |
| 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 |
|---|---|
| K251813 | 2026-02-11 |
| K233425 | 2024-01-25 |
| K193587 | 2020-02-10 |
| K192128 | 2019-10-04 |
| K191732 | 2019-08-30 |
| K171869 | 2018-02-23 |
| K150959 | 2015-09-10 |
| K131012 | 2013-08-23 |
| K073450 | 2008-03-17 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-06-23 | Class II | Labeling design | The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and storage at 5 C to 40 C, the package insert (IFU) is labelled incorrectly. It shows the symbol for sterilization using Ethylene Oxide w | 1337 units | 2020-08-21 |
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.