FDA 510(k)

Canady Flex RoboWrist

K-Number: K212736 · 2022-11-22

Decision Date2022-11-22

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Canady Flex RoboWrist is a medical device manufactured by Us Medical Innovations, LLC. It received FDA 510(k) clearance on 2022-11-22 under approval number K212736. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Canady Flex RoboWrist?

Canady Flex RoboWrist is a medical device that received FDA 510(k) clearance on 2022-11-22. It is manufactured by Us Medical Innovations, LLC. The 510(k) number is K212736.

When was Canady Flex RoboWrist approved by the FDA?

Canady Flex RoboWrist received FDA 510(k) clearance on 2022-11-22, under approval number K212736.

What company makes Canady Flex RoboWrist?

Canady Flex RoboWrist is manufactured by Us Medical Innovations, LLC.

What is the FDA product code for Canady Flex RoboWrist?

The FDA product code for Canady Flex RoboWrist is GCJ.

Other Devices by Us Medical Innovations, LLC

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Official Source

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