GeniSurge 533-005-910T
by Genicon
GeniSurge 533-005-910T is a Class II device made by Genicon, cleared under FDA 510(k) K061417 on 10 Oct 2006 and listed in FDA GUDID since 8 Nov 2017 (UDI-DI 00877972006770), 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 | Number00877972006770 | Date8 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK061417 | Date10 Oct 2006 | StatusActive |
Official records
- AccessGUDID record 00877972006770
- FDA 510(k) database K061417
Across registries
- FDA 510(k) K061417 decided 10 Oct 2006 Active
- FDA GUDID UDI-DI 00877972006770 listed 8 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K061417
- Listed FDA GUDID 00877972006770
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- GeniSurge
- Generic name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
- Model / reference
- 533-005-910T
- Primary DI / UDI-DI
- 00877972006770
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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