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FDA 510(k)

Retraction, CWM-910T, APOLEX Tite

K-Number: K222709 · 2023-03-21

ApplicantChungwoo Co., Ltd.
Decision Date2023-03-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Retraction, CWM-910T, APOLEX Tite is the device name listed in this FDA 510(k) record. The listed applicant is Chungwoo Co., Ltd.. It received FDA 510(k) clearance on 2023-03-21 under 510(k) 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. The listed applicant is Chungwoo Co., Ltd.. The 510(k) number is K222709.

When did Retraction, CWM-910T, APOLEX Tite receive FDA 510(k) clearance?

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

Who is the listed applicant for Retraction, CWM-910T, APOLEX Tite?

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

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 records listing Chungwoo Co., Ltd. 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.

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Official Source

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