Electrode 395 400 015 C
Electrode 395 400 015 C is a Class II device made by SOPRO-COMEG GmbH, cleared under FDA 510(k) K971881 on 12 Aug 1997 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 04059082025841), 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 | Number04059082025841 | Date12 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK971881 | Date12 Aug 1997 | StatusActive |
Official records
- AccessGUDID record 04059082025841
- FDA 510(k) database K971881
Across registries
- FDA 510(k) K971881 decided 12 Aug 1997 Active
- FDA GUDID UDI-DI 04059082025841 listed 12 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K971881
- Listed FDA GUDID 04059082025841
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Electrode
- Generic name
- Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
- Model / reference
- 395 400 015 C
- Primary DI / UDI-DI
- 04059082025841
- 510(k) Number
- FDA product code
- FAS
- GMDN term
- Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
- Device class
- Class II
- Regulation number
- 876.4300
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization