Potenza
by Jeisys Medical Incorporated
Potenza is a Class II device made by Jeisys Medical Incorporated, cleared under FDA 510(k) K231216 on 10 Dec 2024 (3 earlier submissions) and listed in FDA GUDID since 27 Feb 2020 (UDI-DI 08800020111012), 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) | NumberK231216 | Date10 Dec 2024 | StatusActive |
| United States | GUDID listing | Number08800020111012 | Date27 Feb 2020 | StatusListed |
Official records
- AccessGUDID record 08800020111012
- FDA 510(k) database K231216
- FDA 510(k) database K231287
- FDA 510(k) database K201685
- FDA 510(k) database K192545
Across registries
- FDA 510(k) K231216 decided 10 Dec 2024 Active
- FDA GUDID UDI-DI 08800020111012 listed 27 Feb 2020 Listed
Timeline
- Cleared FDA 510(k) K192545
- Listed FDA GUDID 08800020111012
- Cleared FDA 510(k) K201685
- Cleared FDA 510(k) K231287
- Cleared FDA 510(k) K231216
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Electrosurgical system
- Model / reference
- POTENZA
- Primary DI / UDI-DI
- 08800020111012
- 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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