510(k) K241866
K241866 is an FDA 510(k) premarket notification submitted by Convatec Triad Life Sciences, LLC for the device "InnovaMatrix®FD". The FDA issued a decision of Substantially Equivalent on July 26, 2024. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 2024
- Date Received
- June 27, 2024
- Clearance Type
- Special
- 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