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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 the device name listed in this FDA 510(k) record. The listed applicant is Rebotix. It received FDA 510(k) clearance on 2025-08-19 under 510(k) 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. The listed applicant is Rebotix. The 510(k) number is K250387.

When did Remanufactured EndoWrist Long Tip Forceps (420048) receive FDA 510(k) clearance?

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

Who is the listed applicant for Remanufactured EndoWrist Long Tip Forceps (420048)?

The FDA 510(k) record lists Rebotix as the applicant. This does not by itself establish the device manufacturer.

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 records listing Rebotix as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: QSM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252926Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)Restore RoboticsK250417Remanufactured EndoWrist Cobra Grasper (420190)RebotixK250539Remanufactured EndoWrist Tenaculum Forceps (420207)RebotixK250399Remanufactured EndoWrist Cadiere Forceps (420049)RebotixK2426108mm Monopolar Curved Scissors (470179)Iconocare HealthK241872Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix

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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