Clearance Summary
Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) received FDA 510(k) clearance under submission number K252926, sponsored by Restore Robotics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2026-03-26.
- Submission: K252926
- Applicant / Sponsor: Restore Robotics
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2026-03-26
Classification & Regulation
This clearance is catalogued under FDA product code QSM and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.