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.

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: 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.