Clearance Summary
SuperBall Meniscal Repair System received FDA 510(k) clearance under submission number K180191, sponsored by Arcuro Medical , 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 2018-06-05.
- Submission: K180191
- Applicant / Sponsor: Arcuro Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5000
- Decision date: 2018-06-05
Classification & Regulation
This clearance is catalogued under FDA product code GAT and 21 CFR 878.5000, within the General, Plastic Surgery review panel as a Class II device.