Op.n Tracker B A00064
Op.n Tracker B A00064 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 03701311500872), 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 | Number03701311500872 | Date20 Mar 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK242914 | Date7 Mar 2025 | StatusActive |
Official records
- AccessGUDID record 03701311500872
- FDA 510(k) database K242914
Across registries
- FDA 510(k) K242914 decided 7 Mar 2025 Active
- FDA GUDID UDI-DI 03701311500872 listed 20 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K242914
- Listed FDA GUDID 03701311500872
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Op.n Tracker B
- Generic name
- Optical surgical tracking system spatial marker, reusable
- Model / reference
- A00064
- Primary DI / UDI-DI
- 03701311500872
- 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
- Dry Heat Sterilization
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