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FDA 510(k)

Roosin Collagen Dressing

K-Number: K253974 · 2026-06-03

Decision Date2026-06-03
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Roosin Collagen Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Roosin Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K253974. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Roosin Collagen Dressing?

Roosin Collagen Dressing is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Roosin Medical Co., Ltd.. The 510(k) number is K253974.

When did Roosin Collagen Dressing receive FDA 510(k) clearance?

Roosin Collagen Dressing received FDA 510(k) clearance on 2026-06-03, under 510(k) number K253974.

Who is the listed applicant for Roosin Collagen Dressing?

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

What is the FDA product code for Roosin Collagen Dressing?

The FDA product code for Roosin Collagen Dressing is KGN.

Other records listing Roosin Medical 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.

Related Devices (Code: KGN)

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.

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.