Probe 707-005-333
by Genicon
Probe 707-005-333 is a Class II device made by Genicon, cleared under FDA 510(k) K190168 on 14 Mar 2019 (1 earlier submission) and listed in FDA GUDID since 5 May 2017 (UDI-DI 00877972002765), 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 | FDA 510(k)SESE | NumberK190168 | Date14 Mar 2019 | StatusActive |
| United States | GUDID listing | Number00877972002765 | Date5 May 2017 | StatusListed |
Official records
- AccessGUDID record 00877972002765
- FDA 510(k) database K190168
- FDA 510(k) database K041967
Across registries
- FDA 510(k) K190168 decided 14 Mar 2019 Active
- FDA GUDID UDI-DI 00877972002765 listed 5 May 2017 Listed
Timeline
- Cleared FDA 510(k) K041967
- Listed FDA GUDID 00877972002765
- Cleared FDA 510(k) K190168
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Probe
- Generic name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
- Model / reference
- 707-005-333
- Primary DI / UDI-DI
- 00877972002765
- FDA product code
- GCJ
- GMDN term
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization