510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252926Substantially Equivalent

Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)

Restore Robotics, Henderson NV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252926 is the FDA 510(k) clearance record for Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184), a class II device, cleared for Restore Robotics on under FDA product code QSM (System, Surgical, Computer Controlled Instrument, Remanufactured). FDA's definition for product code QSM reads: "As intended with the originally cleared instrument". FDA records list one 510(k) clearance for Restore Robotics. As of , FDA records show no recalls naming K252926.

Clearance record

Decision date
Received
(192 days to decision)
Product code
QSM System, Surgical, Computer Controlled Instrument, Remanufactured
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Restore Robotics 15 Longevity Dr., Henderson NV
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QSM

Trailing 12 months
1 clearance under product code QSM in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QSM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260