510(k) K260596
K260596 is an FDA 510(k) premarket notification submitted by Ventris Medical for the device "Collagen Wound Powder". The FDA issued a decision of Substantially Equivalent on July 2, 2026. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Ventris Medical has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2026
- Date Received
- February 24, 2026
- 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