Robotic Surgical Instruments - Permanent Cautery Hook (470183) +1 more— 510(k) K252926

Name: FDA 510(k) clearance K252926
Creator: U.S. Food and Drug Administration
Published: 2026-03-26

Substantially Equivalent

Restore Robotics

FDA 510(k) clearance K252926 for Robotic Surgical Instruments - Permanent Cautery Hook (470183) +1 more, Substantially Equivalent on 2026-03-26. Applicant: Restore Robotics. Device class: 2.

Summary

Restore Robotics' record lists two Robotic Surgical Instruments: the Permanent Cautery Hook (470183) and the Permanent Cautery Spatula (470184). Both are filed under QSM, remanufactured computer-controlled surgical instrument systems.

Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.

Restore Robotics filed from Henderson, Nevada. Review took 192 calendar days (September 15, 2025 to March 26, 2026).

Clearance details

Device name as filed: Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)
Applicant: Restore Robotics
Product code: Product code QSM
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-09-15
Decision date: 2026-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Henderson, NV, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.