Electrosurgical, Cutting & Coagulation & Accessories
Bipolar Irrigator Integrated Tubing and Bipolar Cord Set, Disposable, Unitized Plug
65manufacturers in China registered for this device type
46catalogue numbers in this listing
9510(k) clearances naming this product code
4recalls on this 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 | Stryker GmbH, Switzerland |
|---|---|
| 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 |
| 510(k) | K935237 |
| Record published | 2016-09-23 |
| Record revised | 2022-09-16 (version 11) |
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, serial number |
| Storage | Storage environment temperature 10 to 38 °C |
| Packaging | Pack of 10 |
| Distribution end date | 2022-02-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6790-100-005 | In distribution | |
| 6700-313-002 | In distribution | |
| 6700-313-600 | In distribution | |
| 6700-313-004 | In distribution | |
| 0233032111 | In distribution | |
| 0233032108 | In distribution | |
| 0242000012 | In distribution | |
| 0406750000 | In distribution | |
| 6700-313-003 | In distribution | |
| 0233032881 | In distribution | |
| 6790-100-001 | In distribution | |
| 0242000024 | In distribution | |
| 6790-100-006 | In distribution | |
| 6790-100-004 | In distribution | |
| 6700-313-304 | In distribution | |
| 6700-313-500 | In distribution | |
| 6700-100-001 | In distribution | |
| 0233032880 | In distribution | |
| 0250015500 | In distribution | |
| 0233410000 | In distribution | |
| 0406850100 | In distribution | |
| 0250015704 | In distribution | |
| 0250070510 | In distribution | |
| 0233032100 | In distribution | |
| 6790-100-003 | In distribution | |
| 6790-100-002 | In distribution | |
| 0272707000 | In distribution | |
| 0250080158 | Diameter: 11.0 Millimeter | Withdrawn |
| 0406760000 | Withdrawn | |
| 0250080155 | Diameter: 8.0 Millimeter | Withdrawn |
| 0250080154 | Diameter: 5.5 Millimeter | Withdrawn |
| 0250080634 | Diameter: 3.5 Millimeter | Withdrawn |
| 0250080208 | Diameter: 6.0 Millimeter | Withdrawn |
| 0250080174 | Diameter: 11.0 Millimeter | Withdrawn |
| 0250080140 | Withdrawn | |
| 0250080171 | Diameter: 5.5 Millimeter | Withdrawn |
| 0250080179 | Diameter: 11.0 Millimeter | Withdrawn |
| 0250080180 | Diameter: 11.0 Millimeter | Withdrawn |
| 0250080176 | Diameter: 5.5 Millimeter | Withdrawn |
| 0250080204 | Withdrawn | |
| 0250080157 | Diameter: 5.5 Millimeter | Withdrawn |
| 0233032114 | Withdrawn | |
| 0250080692 | Diameter: 3.5 Millimeter | Withdrawn |
| 0250080156 | Diameter: 11.0 Millimeter | Withdrawn |
| 0250080207 | Withdrawn | |
| 0250080139 | 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 |
|---|---|
| K221074 | 2022-09-16 |
| K171391 | 2018-01-26 |
| K160050 | 2016-05-03 |
| K160693 | 2016-04-13 |
| K153679 | 2016-01-22 |
| K063480 | 2007-05-22 |
| K061225 | 2006-09-14 |
| K033232 | 2004-02-25 |
| K861742 | 1986-07-23 |
Recalls Naming This Product
2 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 | Closed |
|---|---|---|---|---|---|---|---|
| Stryker Endoscopy | 510(k) number | 2014-04-16 | Class II | Reprocessing Controls | Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing. | 2591 trays | 2014-08-18 |
| Stryker Endoscopy | 510(k) number | 2012-06-19 | Class II | Process control | The gravity steam, Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed from the “Instructions for Use”; due to the firm’s evaluation that identified original validation was not done at worst case conditions. | 6388 units | 2012-10-23 |
Recalls
4 of these are 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 |
|---|---|---|---|---|---|
| 2020-03-26 | Class II | Under Investigation by firm | Due to a distribution error, product from the affected lot was shipped expired. | 40 units | 2020-07-15 |
| 2020-01-13 | Class II | Under Investigation by firm | Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user. | 15150 | 2021-08-10 |
| 2020-01-13 | Class II | Under Investigation by firm | Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user. | 15150 | 2021-08-10 |
| 2020-01-13 | Class II | Under Investigation by firm | Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user. | 15150 | 2021-08-10 |
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.