INTRAgen
by Jeisys Medical Incorporated
INTRAgen 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 31 Oct 2016 (UDI-DI 08800020105011), active as of 8 Jun 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 | Number08800020105011 | Date31 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142833 | Date4 Jun 2015 | StatusActive |
Official records
- AccessGUDID record 08800020105011
- FDA 510(k) database K142833
Across registries
- FDA 510(k) K142833 decided 4 Jun 2015 Active
- FDA GUDID UDI-DI 08800020105011 listed 31 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K142833
- Listed FDA GUDID 08800020105011
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Electrosurgical system
- Model / reference
- INTRAgen
- Primary DI / UDI-DI
- 08800020105011
- 510(k) Number
- FDA product code
- OUH, GEI
- GMDN term
- Electrosurgical system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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