GENERIC Surgical Instruments 91.002.5004
GENERIC Surgical Instruments 91.002.5004 is a Class I device made by CTL Medical Corporation, cleared under FDA 510(k) K091278 on 28 Jan 2010 and listed in FDA GUDID since 30 Sep 2023 (UDI-DI 00841732163515), 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 | Number00841732163515 | Date30 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK091278 | Date28 Jan 2010 | StatusActive |
Official records
- AccessGUDID record 00841732163515
- FDA 510(k) database K091278
Across registries
- FDA 510(k) K091278 decided 28 Jan 2010 Active
- FDA GUDID UDI-DI 00841732163515 listed 30 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K091278
- Listed FDA GUDID 00841732163515
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- GENERIC Surgical Instruments
- Generic name
- Surgical mallet
- Model / reference
- 91.002.5004
- Primary DI / UDI-DI
- 00841732163515
- FDA product code
- HXL
- GMDN term
- Surgical mallet
- Device class
- Class I
- Regulation number
- 878.4800
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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