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FDA 510(k)

CollOvine™ Wound Dressing

K-Number: K242985 · 2025-06-20

ApplicantOvigenex, LLC
Decision Date2025-06-20
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

CollOvine™ Wound Dressing is a medical device manufactured by Ovigenex, LLC. It received FDA 510(k) clearance on 2025-06-20 under approval 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. It is manufactured by Ovigenex, LLC. The 510(k) number is K242985.

When was CollOvine™ Wound Dressing approved by the FDA?

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

What company makes CollOvine™ Wound Dressing?

CollOvine™ Wound Dressing is manufactured by Ovigenex, LLC.

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

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

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING NCT07494773 Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40574448 [Research and Discussion on the Whole Lifecycle Supervision of Typical Class Ⅱ Wound Dressing Products]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Ovigenex, LLC

K253140CollOvine™ Wound Powder

Related Devices (Code: KGN)

K160136Flowable Wound MatrixCook Biotech Incorporated K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. K153754MicroMatrixAcell, Inc. K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) K171842Geistlich Wound MatrixGeistlich Pharma AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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