510(k) K242985
K242985 is an FDA 510(k) premarket notification submitted by Ovigenex, LLC for the device "CollOvine Wound Dressing". The FDA issued a decision of Substantially Equivalent on June 20, 2025. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Ovigenex, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2025
- Date Received
- September 26, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressing With Animal-Derived Material(S)
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type