FDA 510(k)

CollOvine™ Wound Dressing

K-Number: K242985 · 2025-06-20

Decision Date2025-06-20

Product CodeKGN

DecisionSubstantially Equivalent

Device Summary

CollOvine™ Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Ovigenex, LLC. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K242985. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CollOvine™ Wound Dressing?

CollOvine™ Wound Dressing is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Ovigenex, LLC. The 510(k) number is K242985.

When did CollOvine™ Wound Dressing receive FDA 510(k) clearance?

CollOvine™ Wound Dressing received FDA 510(k) clearance on 2025-06-20, under 510(k) number K242985.

Who is the listed applicant for CollOvine™ Wound Dressing?

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

What is the FDA product code for CollOvine™ Wound Dressing?

The FDA product code for CollOvine™ Wound Dressing is KGN.

Other records listing Ovigenex, LLC 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.

K253140CollOvine™ Wound Powder

Related Devices (Code: KGN)

K260596Collagen Wound PowderVentris Medical K260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., Ltd.

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.