AngioSystems Tray KM5024-8
AngioSystems Tray KM5024-8 is a Class I device made by Angiosystems, Incorporated, cleared under FDA 510(k) K905462 on 6 Feb 1991 and listed in FDA GUDID since 25 Jun 2025 (UDI-DI 00816611026557), 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 | Number00816611026557 | Date25 Jun 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK905462 | Date6 Feb 1991 | StatusActive |
Official records
- AccessGUDID record 00816611026557
- FDA 510(k) database K905462
Across registries
- FDA 510(k) K905462 decided 6 Feb 1991 Active
- FDA GUDID UDI-DI 00816611026557 listed 25 Jun 2025 Listed
Timeline
- Cleared FDA 510(k) K905462
- Listed FDA GUDID 00816611026557
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AngioSystems Tray
- Generic name
- General surgical procedure kit, medicated
- Model / reference
- KM5024-8
- Primary DI / UDI-DI
- 00816611026557
- 510(k) Number
- FDA product code
- LRP
- GMDN term
- General surgical procedure kit, medicated
- Device class
- Class I
- Regulation number
- 878.4800
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide
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