Swaroplate
The FDA filing names SWAROPLATE neutral electrodes and describes them as an accessory for monopolar high-frequency surgery. The electrode provides a broad, low-impedance skin contact for…
The FDA filing names SWAROPLATE neutral electrodes and describes them as an accessory for monopolar high-frequency surgery.
The electrode provides a broad, low-impedance skin contact for return of electrical current to the generator. The filing describes it as self-adhesive and ready to use.
Use Boundary
The source says SWAROPLATE electrodes are disposable and excludes use in High Current Mode, described there by high current or extended activation conditions.
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 | Nissha Medical Technologies Limited, United Kingdom |
|---|---|
| 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) | K203494 |
| Record published | 2021-04-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 0 to 40 °C |
| Packaging | Box of 8, case of 96, box of 50, case of 300, case of 600, box of 25 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1210H | 5 | In distribution | |
| 1268H | In distribution | ||
| 1213H | In distribution | ||
| 1222H | In distribution | ||
| 1285H | In distribution | ||
| 1203H | 5 | In distribution | |
| 1222H | 5 | In distribution | |
| 1271H | In distribution | ||
| 1226H | 5 | In distribution | |
| 1201H | In distribution | ||
| 1280H | In distribution | ||
| 1269H | In distribution | ||
| 1251H | In distribution | ||
| 1201H | 5 | In distribution | |
| 1201H | 2 | In distribution | |
| 1283H | 5 | In distribution | |
| 1213H | 5 | In distribution | |
| 1283H | In distribution | ||
| 1223H | 5 | In distribution | |
| 1210H | In distribution | ||
| 1220H | In distribution | ||
| 1203H | In distribution | ||
| 1202H | 5 | In distribution | |
| 1211H | 5 | In distribution | |
| 1288H | In distribution | ||
| 1262H | In distribution | ||
| 1259H | In distribution | ||
| 1212H | In distribution | ||
| 1226H | In distribution | ||
| 1258H | In distribution | ||
| 1261H | In distribution | ||
| 1257H | In distribution | ||
| 1202H | In distribution | ||
| 1274H | In distribution | ||
| 1220H | 5 | In distribution | |
| 1212H | 5 | In distribution | |
| 1252H | In distribution | ||
| 1280H | 5 | In distribution | |
| 1286H | In distribution | ||
| 1223H | In distribution | ||
| 1263H | In distribution | ||
| 1211H | In distribution | ||
| 1255H | In distribution | ||
| 1253H | In distribution |
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 |
|---|---|
| K203494 | 2021-02-23 |
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.