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FDA 510(k)

Remanufactured EndoWrist Long Tip Forceps (420048)

K-Number: K250387 · 2025-08-19

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

Device Summary

Remanufactured EndoWrist Long Tip Forceps (420048) is a medical device manufactured by Rebotix. It received FDA 510(k) clearance on 2025-08-19 under approval number K250387. 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 Long Tip Forceps (420048)?

Remanufactured EndoWrist Long Tip Forceps (420048) is a medical device that received FDA 510(k) clearance on 2025-08-19. It is manufactured by Rebotix. The 510(k) number is K250387.

When was Remanufactured EndoWrist Long Tip Forceps (420048) approved by the FDA?

Remanufactured EndoWrist Long Tip Forceps (420048) received FDA 510(k) clearance on 2025-08-19, under approval number K250387.

What company makes Remanufactured EndoWrist Long Tip Forceps (420048)?

Remanufactured EndoWrist Long Tip Forceps (420048) is manufactured by Rebotix.

What is the FDA product code for Remanufactured EndoWrist Long Tip Forceps (420048)?

The FDA product code for Remanufactured EndoWrist Long Tip Forceps (420048) is QSM.

Other Devices by Rebotix

K241872Remanufactured EndoWrist ProGrasp Forceps (420093) K250417Remanufactured EndoWrist Cobra Grasper (420190) K250399Remanufactured EndoWrist Cadiere Forceps (420049) K250539Remanufactured EndoWrist Tenaculum Forceps (420207)

Related Devices (Code: QSM)

K2104788mm Monopolar Curved ScissorsIconocare Health K241872Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix K250417Remanufactured EndoWrist Cobra Grasper (420190)Rebotix K250399Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix K250539Remanufactured EndoWrist Tenaculum Forceps (420207)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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