CollOvine Wound Powder— 510(k) K253140
Substantially EquivalentOvigenex, LLC
FDA 510(k) clearance K253140 for CollOvine Wound Powder, Substantially Equivalent on 2026-02-10. Applicant: Ovigenex, LLC. Device class: Unclassified.
Summary
Ovigenex's CollOvine Wound Powder is filed under product code KGN (Wound Dressing With Animal-Derived Material(S)). The record doesn't describe the powder beyond its name and that code name.
Class U, with no regulation number. The classification panel is listed as Unknown, and the General, Plastic Surgery review panel handled it as a Traditional 510(k).
Ovigenex filed from Dominguez Hills, California. The decision came 138 calendar days after FDA received it (September 25, 2025 to February 10, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Ovigenex, LLC
- Product code
- Product code KGN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dominguez Hills, CA, US
Recent devices under product code KGN
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view allAdverse events under product code KGN
product code KGN- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . 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.