ClearanceBrief
Panels › Gastroenterology, Urology › Product code QSM · Class 2

System, Surgical, Computer Controlled Instrument, Remanufactured

Regulation 876.1500

1510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in QSM

Company510(k)sRecalls
Rebotix50
Iconocare Health20
Restore Robotics10
Decided510(k)Device and applicantCode
Mar 26, 2026K252926Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula
Restore Robotics
QSM
Aug 20, 2025K250417Remanufactured EndoWrist Cobra Grasper (420190)
Rebotix
QSM
Aug 19, 2025K250539Remanufactured EndoWrist Tenaculum Forceps (420207)
Rebotix
QSM
Aug 19, 2025K250399Remanufactured EndoWrist Cadiere Forceps (420049)
Rebotix
QSM
Aug 19, 2025K250387Remanufactured EndoWrist Long Tip Forceps (420048)
Rebotix
QSM
Mar 11, 2025K2426108mm Monopolar Curved Scissors (470179)
Iconocare Health
QSM
Nov 7, 2024K241872Remanufactured EndoWrist ProGrasp Forceps (420093)
Rebotix
QSM
Sep 30, 2022K2104788mm Monopolar Curved Scissors
Iconocare Health
QSM

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