Op.n™ Patient Tracker A60019
Op.n™ Patient Tracker A60019 is a Class II device made by Ecential Robotics, cleared under FDA 510(k) K261113 on 22 Jul 2026 and listed in FDA GUDID since 13 Sep 2026 (UDI-DI 03701311501565), 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 | Number03701311501565 | Date13 Sep 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK261113 | Date22 Jul 2026 | StatusActive |
Official records
- AccessGUDID record 03701311501565
- FDA 510(k) database K261113
Across registries
- FDA 510(k) K261113 decided 22 Jul 2026 Active
- FDA GUDID UDI-DI 03701311501565 listed 13 Sep 2026 Listed
Timeline
- Cleared FDA 510(k) K261113
- Listed FDA GUDID 03701311501565
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Op.n™ Patient Tracker
- Generic name
- Optical surgical tracking system spatial marker, reusable
- Model / reference
- A60019
- Primary DI / UDI-DI
- 03701311501565
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Optical surgical tracking system spatial marker, reusable
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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