Clearance Summary
Endoform Dermal Template received FDA 510(k) clearance under submission number K260669, sponsored by Aroa Biosurgery , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2026-06-24.
- Submission: K260669
- Applicant / Sponsor: Aroa Biosurgery , Ltd.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2026-06-24
Classification & Regulation
This clearance is catalogued under FDA product code KGN , within the Unknown review panel as a device.