FDA 510(k)

Retraction, CWM-910T, APOLEX Tite

K-Number: K222709 · 2023-03-21

Decision Date2023-03-21

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Retraction, CWM-910T, APOLEX Tite is a medical device manufactured by Chungwoo Co., Ltd.. It received FDA 510(k) clearance on 2023-03-21 under approval number K222709. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Retraction, CWM-910T, APOLEX Tite?

Retraction, CWM-910T, APOLEX Tite is a medical device that received FDA 510(k) clearance on 2023-03-21. It is manufactured by Chungwoo Co., Ltd.. The 510(k) number is K222709.

When was Retraction, CWM-910T, APOLEX Tite approved by the FDA?

Retraction, CWM-910T, APOLEX Tite received FDA 510(k) clearance on 2023-03-21, under approval number K222709.

What company makes Retraction, CWM-910T, APOLEX Tite?

Retraction, CWM-910T, APOLEX Tite is manufactured by Chungwoo Co., Ltd..

What is the FDA product code for Retraction, CWM-910T, APOLEX Tite?

The FDA product code for Retraction, CWM-910T, APOLEX Tite is GEI.

Other Devices by Chungwoo Co., Ltd.

K233120CWM-930S, FIXER DV9

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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.