K252926
- 510(k) number
- K252926
- Device name
- Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)
- Applicant
- Restore Robotics NV · US
- Product code
- QSM — System, Surgical, Computer Controlled Instrument, Re
- Decision date
- 2026-03-26
- Date received
- 2025-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K252926.pdf
Official FDA record: K252926
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.