510(k) K260669
K260669 is an FDA 510(k) premarket notification submitted by Aroa Biosurgery , Ltd. for the device "Endoform Dermal Template". The FDA issued a decision of Substantially Equivalent on Jun 24, 2026. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Aroa Biosurgery , Ltd. has 9 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 24, 2026
- Date Received
- Mar 2, 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
- Review Panel
- SU
- Submission Type
- 510(k)