PlasmaBlade™ X
PlasmaBlade X is a single-use monopolar radiofrequency instrument for soft-tissue cutting and coagulation with a compatible surgical generator. It uses a bendable blade and telescoping…
PlasmaBlade X is a single-use monopolar radiofrequency instrument for soft-tissue cutting and coagulation with a compatible surgical generator. It uses a bendable blade and telescoping shaft for standard or extended reach.
The handpiece incorporates a suction lumen for smoke and fluid evacuation. The 3.0S LIGHT version adds LED illumination near the blade to light the surgical field.
Listed Item
Plasmabladex PS210-030S-LIGHT 3.0SL Pink
Controls and Components
The instrument can be activated through its integrated hand switch or a compatible footswitch. The blade is coated stainless steel, and the device is supplied ethylene-oxide-sterilized. It forms the disposable electrode portion of the generator-based surgery system.
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 | Medtronic Navigation, Inc., United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K193579 |
| Record published | 2020-05-10 |
| Record revised | 2025-07-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 10 to 32 °C; Storage environment humidity 0 to 85 % RH; Storage environment temperature 50 to 90 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PS210-030S-LIGHT | In distribution | |
| PS210-030S | In distribution | |
| PS200-041S | In distribution | |
| PS200-040 | In distribution | |
| PS200-041S | In distribution | |
| PS210-030S | In distribution | |
| PS210-030S-LIGHT | In distribution | |
| PS200-040 | In distribution | |
| PS210-030S-LIGHT | In distribution | |
| PS200-041S | 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 |
|---|---|
| K193579 | 2020-03-24 |
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 |
|---|---|---|---|---|---|
| 2013-11-12 | Class II | Device Design | The internal protection circuitry on the electrosurgical output that prevents a patient from exposure to DC voltage when the device is activated is being compromised during normal use. | 242 devices | 2014-04-03 |
| 2005-02-07 | Not classified | Other | The tip may separate from the device and render it unusable | 588 units | 2005-04-20 |
| 2004-07-22 | Not classified | Other | Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing. | 96 units | 2004-10-04 |
| 2004-07-22 | Not classified | Other | Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing. | 164 units | 2004-10-04 |
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.