Op.n Camera I00026
Op.n Camera I00026 is a Class II device made by Ecential Robotics, cleared under FDA 510(k) K242914 on 7 Mar 2025 and listed in FDA GUDID since 20 Mar 2025 (UDI-DI 03701311501275), 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 | Number03701311501275 | Date20 Mar 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK242914 | Date7 Mar 2025 | StatusActive |
Official records
- AccessGUDID record 03701311501275
- FDA 510(k) database K242914
Across registries
- FDA 510(k) K242914 decided 7 Mar 2025 Active
- FDA GUDID UDI-DI 03701311501275 listed 20 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K242914
- Listed FDA GUDID 03701311501275
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Op.n Camera
- Generic name
- Optical surgical navigation/tracking system
- Model / reference
- I00026
- Primary DI / UDI-DI
- 03701311501275
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Optical surgical navigation/tracking system
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Optical surgical navigation device tracking system.