Remanufactured EndoWrist Cobra Grasper (420190)
K-Number: K250417 · 2025-08-20
ApplicantRebotix
Decision Date2025-08-20
Product CodeQSM
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Remanufactured EndoWrist Cobra Grasper (420190) is a medical device manufactured by Rebotix. It received FDA 510(k) clearance on 2025-08-20 under approval number K250417. 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 Cobra Grasper (420190)?
Remanufactured EndoWrist Cobra Grasper (420190) is a medical device that received FDA 510(k) clearance on 2025-08-20. It is manufactured by Rebotix. The 510(k) number is K250417.
When was Remanufactured EndoWrist Cobra Grasper (420190) approved by the FDA?
Remanufactured EndoWrist Cobra Grasper (420190) received FDA 510(k) clearance on 2025-08-20, under approval number K250417.
What company makes Remanufactured EndoWrist Cobra Grasper (420190)?
Remanufactured EndoWrist Cobra Grasper (420190) is manufactured by Rebotix.
What is the FDA product code for Remanufactured EndoWrist Cobra Grasper (420190)?
The FDA product code for Remanufactured EndoWrist Cobra Grasper (420190) is QSM.
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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.