INTRAGen Handpiece
by Jeisys Medical Incorporated
INTRAGen Handpiece is a Class II device made by Jeisys Medical Incorporated, cleared under FDA 510(k) K142833 on 4 Jun 2015 and listed in FDA GUDID since 29 Jul 2026 (UDI-DI 08800020110688), 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 | Number08800020110688 | Date29 Jul 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142833 | Date4 Jun 2015 | StatusActive |
Official records
- AccessGUDID record 08800020110688
- FDA 510(k) database K142833
Across registries
- FDA 510(k) K142833 decided 4 Jun 2015 Active
- FDA GUDID UDI-DI 08800020110688 listed 29 Jul 2026 Listed
Timeline
- Cleared FDA 510(k) K142833
- Listed FDA GUDID 08800020110688
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Electrosurgical system
- Model / reference
- INTRAGen Handpiece
- Primary DI / UDI-DI
- 08800020110688
- 510(k) Number
- FDA product code
- GEI, OUH
- GMDN term
- Electrosurgical system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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