Clearance Summary
Endoform Reconstructive Template - Non Absorbable received FDA 510(k) clearance under submission number K181935, sponsored by Aroa Biosurgery , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2018-12-04.
- Submission: K181935
- Applicant / Sponsor: Aroa Biosurgery , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2018-12-04
Classification & Regulation
This clearance is catalogued under FDA product code FTL and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.