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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Surgical, Computer Controlled Instrument, Remanufactured
510(k) Number K252926
Device Name Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)
Applicant
Restore Robotics
15 Longevity Dr.
Bldg. C
Henderson,  NV  89014
Applicant Contact Kevin May
Correspondent
Restore Robotics
15 Longevity Dr.
Bldg. C
Henderson,  NV  89014
Correspondent Contact Kevin May
Regulation Number876.1500
Classification Product Code
QSM  
Subsequent Product Code
NAY  
Date Received09/15/2025
Decision Date 03/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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