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FDA 510(k)

RedEx

K-Number: K211234 · 2021-09-17

ApplicantAdvanced Surgical Concepts, Ltd.
Decision Date2021-09-17
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RedEx is a medical device manufactured by Advanced Surgical Concepts, Ltd.. It received FDA 510(k) clearance on 2021-09-17 under approval number K211234. 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 RedEx?

RedEx is a medical device that received FDA 510(k) clearance on 2021-09-17. It is manufactured by Advanced Surgical Concepts, Ltd.. The 510(k) number is K211234.

When was RedEx approved by the FDA?

RedEx received FDA 510(k) clearance on 2021-09-17, under approval number K211234.

What company makes RedEx?

RedEx is manufactured by Advanced Surgical Concepts, Ltd..

What is the FDA product code for RedEx?

The FDA product code for RedEx is GCJ.

Other Devices by Advanced Surgical Concepts, Ltd.

DEN150028PneumoLiner DEN170075ContainOR

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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.

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