FDA.report

Product code QSM

Device name
System, Surgical, Computer Controlled Instrument, Remanufactured
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.1500
Review panel
SU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
As intended with the originally cleared instrument.
Source
FDA openFDA device classification dataset

Related 510(k) Records

510(k)DeviceApplicantDecision date
K252926Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)Restore Robotics2026-03-26
K250417Remanufactured EndoWrist Cobra Grasper (420190)Rebotix2025-08-20
K250387Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix2025-08-19
K250399Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix2025-08-19
K250539Remanufactured EndoWrist Tenaculum Forceps (420207)Rebotix2025-08-19
K2426108mm Monopolar Curved Scissors (470179)Iconocare Health2025-03-11
K241872Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix2024-11-07
K2104788mm Monopolar Curved ScissorsIconocare Health2022-09-30

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