CollOvine Wound Dressing— 510(k) K242985

Name: FDA 510(k) clearance K242985
Creator: U.S. Food and Drug Administration
Published: 2025-06-20

Substantially Equivalent

Ovigenex, LLC

FDA 510(k) clearance K242985 for CollOvine Wound Dressing, Substantially Equivalent on 2025-06-20. Applicant: Ovigenex, LLC. Device class: Unclassified.

Clearance details

Applicant: Ovigenex, LLC
Product code: Code KGN
Device class: Unclassified
Advisory panel: Unknown
Date received: 2024-09-26
Decision date: 2025-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dominguez Hills, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KGN

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K260652 — ColActive Plus2026-09-09
K260711 — Accelagen Plus Surgical Matrix, 1cc (CG-01AP) +4 more2026-08-27
K260596 — Collagen Wound Powder2026-07-02
K260669 — Endoform Dermal Template2026-06-24
K253521 — ECMT-100 WMD2026-06-18

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K253140 — CollOvine Wound Powder2026-02-10

Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.