Endo SNAP
Endo SNAP is a Class II device made by Surgical Theater LLC, cleared under FDA 510(k) K160584 on 28 Jun 2016 and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 00863157000329), active as of 19 Oct 2026. 4 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00863157000329 | Date13 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160584 | Date28 Jun 2016 | StatusActive |
Official records
- AccessGUDID record 00863157000329
- FDA 510(k) database K160584
Across registries
- FDA 510(k) K160584 decided 28 Jun 2016 Active
- FDA GUDID UDI-DI 00863157000329 listed 13 Sep 2016 Listed
Recalls
-
- Terminated Z-0322-2026
- Terminated Z-0320-2026
- Terminated Z-0321-2026
- Terminated Z-0323-2026
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Timeline
- Cleared FDA 510(k) K160584
- Listed FDA GUDID 00863157000329
- Recall initiated FDA recalls Z-0322-2026
- Recall initiated FDA recalls Z-0320-2026
- Recall initiated FDA recalls Z-0321-2026
- Recall initiated FDA recalls Z-0323-2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Surgical planning/navigation-enhancement system
- Model / reference
- Endo SNAP
- Primary DI / UDI-DI
- 00863157000329
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Surgical planning/navigation-enhancement system
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Surgical planning/navigation-enhancement system.