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510(k) K250399

Remanufactured EndoWrist Cadiere Forceps (420049) by Rebotix — Product Code QSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2025
Date Received
February 12, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Surgical, Computer Controlled Instrument, Remanufactured
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

As intended with the originally cleared instrument.

Other clearances by Rebotix

  • K250417 — Remanufactured EndoWrist Cobra Grasper (420190) (August 20, 2025)
  • K250387 — Remanufactured EndoWrist Long Tip Forceps (420048) (August 19, 2025)
  • K250539 — Remanufactured EndoWrist Tenaculum Forceps (420207) (August 19, 2025)
  • K241872 — Remanufactured EndoWrist ProGrasp Forceps (420093) (November 7, 2024)

Other clearances for product code QSM

  • K252926 — Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical (March 26, 2026)
  • K250417 — Remanufactured EndoWrist Cobra Grasper (420190) (August 20, 2025)
  • K250387 — Remanufactured EndoWrist Long Tip Forceps (420048) (August 19, 2025)
  • K250539 — Remanufactured EndoWrist Tenaculum Forceps (420207) (August 19, 2025)
  • K242610 — 8mm Monopolar Curved Scissors (470179) (March 11, 2025)
  • K241872 — Remanufactured EndoWrist ProGrasp Forceps (420093) (November 7, 2024)
  • K210478 — 8mm Monopolar Curved Scissors (September 30, 2022)