Celfirm
Celfirm 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) K172023 on 13 Oct 2017 and listed in FDA GUDID since 23 Feb 2018 (UDI-DI 08809502330026), active as of 21 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 | Number08809502330026 | Date23 Feb 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172023 | Date13 Oct 2017 | StatusActive |
Official records
- AccessGUDID record 08809502330026
- FDA 510(k) database K172023
Across registries
- FDA 510(k) K172023 decided 13 Oct 2017 Active
- FDA GUDID UDI-DI 08809502330026 listed 23 Feb 2018 Listed
Timeline
- Cleared FDA 510(k) K172023
- Listed FDA GUDID 08809502330026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Electrosurgical system
- Model / reference
- CELFIRM
- Primary DI / UDI-DI
- 08809502330026
- 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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