PlasmaKinetic 3905
PlasmaKinetic 3905 is an electrosurgical system (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Gyrus Acmi, Inc., cleared under FDA 510(k) K031085 on 21 Jul 2003 and listed in FDA GUDID since 3 Oct 2016 (UDI-DI 00821925009820), 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 | Number00821925009820 | Date3 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK031085 | Date21 Jul 2003 | StatusActive |
Official records
- AccessGUDID record 00821925009820
- FDA 510(k) database K031085
Across registries
- FDA 510(k) K031085 decided 21 Jul 2003 Active
- FDA GUDID UDI-DI 00821925009820 listed 3 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K031085
- Listed FDA GUDID 00821925009820
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PlasmaKinetic
- Generic name
- Electrosurgical system
- Model / reference
- 3905
- Primary DI / UDI-DI
- 00821925009820
- 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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