510(k) K260161
K260161 is an FDA 510(k) premarket notification submitted by UC-CARE , Ltd. for the device "SmartGuide Disposable Guides and Grids". The FDA issued a decision of Substantially Equivalent on Jul 30, 2026. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. UC-CARE , Ltd. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 30, 2026
- Date Received
- Jan 20, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Ultrasonic, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type
- 510(k)