510(k) K241904
K241904 is an FDA 510(k) premarket notification submitted by Fesariustherapeutics, Inc. for the device "DermiSphere Dermal Template". The FDA issued a decision of Substantially Equivalent on Jan 6, 2025. 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
- Jan 6, 2025
- Date Received
- Jul 1, 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