Prosurg HFH12
by Prosurg, Inc
Prosurg HFH12 is a flexible video cystoscope (FDA Class II; FDA product code FAJ, Cystoscope And Accessories, Flexible/Rigid) made by Prosurg, Inc, cleared under FDA 510(k) K120766 on 11 Sep 2012 and listed in FDA GUDID since 21 May 2020 (UDI-DI 00851545007838), active as of 22 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 | Number00851545007838 | Date21 May 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120766 | Date11 Sep 2012 | StatusActive |
Official records
- AccessGUDID record 00851545007838
- FDA 510(k) database K120766
Across registries
- FDA 510(k) K120766 decided 11 Sep 2012 Active
- FDA GUDID UDI-DI 00851545007838 listed 21 May 2020 Listed
Timeline
- Cleared FDA 510(k) K120766
- Listed FDA GUDID 00851545007838
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Prosurg
- Generic name
- Flexible video cystoscope, single-use
- Model / Ref / Catalog
- HFH12
- Primary DI / UDI-DI
- 00851545007838
- 510(k) Number
- FDA product code
- FAJ
- GMDN term
- Flexible video cystoscope, single-use
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide
Similar devices in this category
Other devices filed under Flexible video cystoscope, single-use.