Clearance Summary
Symani Surgical System received FDA 510(k) clearance under submission number DEN230032, sponsored by Mmi North America, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-04-05.
- Submission: DEN230032
- Applicant / Sponsor: Mmi North America, Inc.
- Clearance pathway: Direct
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4963
- Decision date: 2024-04-05
Classification & Regulation
This clearance is catalogued under FDA product code SAQ and 21 CFR 878.4963, within the General, Plastic Surgery review panel as a Class II device.