Handpiece P/B
Handpiece P/B is an electrosurgical system (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by VIOL Co., Ltd., cleared under FDA 510(k) K200185 on 22 Apr 2020 and listed in FDA GUDID since 14 Jan 2021 (UDI-DI 08809502330170), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08809502330170 | Date14 Jan 2021 | StatusListed |
| United States | FDA 510(k) | NumberK200185 | Date22 Apr 2020 | StatusActive |
Official records
- AccessGUDID record 08809502330170
- FDA 510(k) database K200185
Across registries
- FDA 510(k) K200185 decided 22 Apr 2020 Active
- FDA GUDID UDI-DI 08809502330170 listed 14 Jan 2021 Listed
Timeline
- Cleared FDA 510(k) K200185
- Listed FDA GUDID 08809502330170
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Handpiece
- Generic name
- Electrosurgical system
- Model / reference
- P/B
- Primary DI / UDI-DI
- 08809502330170
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Electrosurgical system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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