Clearance Summary
Anovo Surgical System (6Ne) received FDA 510(k) clearance under submission number K260804, 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 2026-07-22.
- Submission: K260804
- Applicant / Sponsor: Momentis Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4964
- Decision date: 2026-07-22
Classification & Regulation
This clearance is catalogued under FDA product code SCV and 21 CFR 878.4964, within the General, Plastic Surgery review panel as a Class II device.