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FDA 510(k)

Remanufactured EndoWrist Tenaculum Forceps (420207)

K-Number: K250539 · 2025-08-19

ApplicantRebotix
Decision Date2025-08-19
Product CodeQSM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Remanufactured EndoWrist Tenaculum Forceps (420207) is a medical device manufactured by Rebotix. It received FDA 510(k) clearance on 2025-08-19 under approval number K250539. The device is classified under product code QSM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Remanufactured EndoWrist Tenaculum Forceps (420207)?

Remanufactured EndoWrist Tenaculum Forceps (420207) is a medical device that received FDA 510(k) clearance on 2025-08-19. It is manufactured by Rebotix. The 510(k) number is K250539.

When was Remanufactured EndoWrist Tenaculum Forceps (420207) approved by the FDA?

Remanufactured EndoWrist Tenaculum Forceps (420207) received FDA 510(k) clearance on 2025-08-19, under approval number K250539.

What company makes Remanufactured EndoWrist Tenaculum Forceps (420207)?

Remanufactured EndoWrist Tenaculum Forceps (420207) is manufactured by Rebotix.

What is the FDA product code for Remanufactured EndoWrist Tenaculum Forceps (420207)?

The FDA product code for Remanufactured EndoWrist Tenaculum Forceps (420207) is QSM.

Other Devices by Rebotix

K241872Remanufactured EndoWrist ProGrasp Forceps (420093) K250417Remanufactured EndoWrist Cobra Grasper (420190) K250387Remanufactured EndoWrist Long Tip Forceps (420048) K250399Remanufactured EndoWrist Cadiere Forceps (420049)

Related Devices (Code: QSM)

K2104788mm Monopolar Curved ScissorsIconocare Health K241872Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix K250417Remanufactured EndoWrist Cobra Grasper (420190)Rebotix K250387Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix K250399Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix K2426108mm Monopolar Curved Scissors (470179)Iconocare Health

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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