Clearance Summary
Sweden & Martina Surgical Trays received FDA 510(k) clearance under submission number K222640, sponsored by Sweden & Martina S.P.A.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2023-05-26.
- Submission: K222640
- Applicant / Sponsor: Sweden & Martina S.P.A.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2023-05-26
Classification & Regulation
This clearance is catalogued under FDA product code KCT and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.