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FDA 510(k)

CollOvine™ Wound Powder

K-Number: K253140 · 2026-02-10

ApplicantOvigenex, LLC
Decision Date2026-02-10
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

CollOvine™ Wound Powder is a medical device manufactured by Ovigenex, LLC. It received FDA 510(k) clearance on 2026-02-10 under approval number K253140. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CollOvine™ Wound Powder?

CollOvine™ Wound Powder is a medical device that received FDA 510(k) clearance on 2026-02-10. It is manufactured by Ovigenex, LLC. The 510(k) number is K253140.

When was CollOvine™ Wound Powder approved by the FDA?

CollOvine™ Wound Powder received FDA 510(k) clearance on 2026-02-10, under approval number K253140.

What company makes CollOvine™ Wound Powder?

CollOvine™ Wound Powder is manufactured by Ovigenex, LLC.

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

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

Other Devices by Ovigenex, LLC

Related Devices (Code: KGN)

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.