510(k) K252926
K252926 is an FDA 510(k) premarket notification submitted by Restore Robotics for the device "Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)". The FDA issued a decision of Substantially Equivalent on Mar 26, 2026. The device falls under product code QSM (System, Surgical, Computer Controlled Instrument, Remanufactured), a Class II device regulated under 21 CFR 876.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 26, 2026
- Date Received
- Sep 15, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Surgical, Computer Controlled Instrument, Remanufactured
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type
As intended with the originally cleared instrument.