Instrusafe In-2020-4495
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00385640064538 | Date8 Apr 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151166 | Date18 Aug 2015 | StatusActive |
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Instrusafe
- Generic name
- Instrument tray, reusable
- Model / reference
- IN-2020-4495
- Primary DI / UDI-DI
- 00385640064538
- FDA product code
- KCT
- GMDN term
- Instrument tray, reusable
- Device class
- Class II
- Regulation number
- 880.6850
- GUDID distribution status
- In Commercial Distribution
Other devices from Summit Medical, LLC
Properties
Other properties (12)
- Supplied sterile: No
- Sterilise before use: No
- Single use: No
- Implantable: No
- Contains latex: No
- Prescription use: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Expiration date: No