Clearance Summary
Anovo Surgical System (6Ne) received FDA 510(k) clearance under submission number K250591, sponsored by Momentis Surgical , 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 2025-06-06.
- Submission: K250591
- Applicant / Sponsor: Momentis Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4961
- Decision date: 2025-06-06
Classification & Regulation
This clearance is catalogued under FDA product code QNM and 21 CFR 878.4961, within the General, Plastic Surgery review panel as a Class II device.