Clearance Summary
EXPRESSAIRE TORUNIQUET SYSTEM received FDA 510(k) clearance under submission number K955552, sponsored by Smith & Nephew Richards, Inc.. 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 1996-01-05.
- Submission: K955552
- Applicant / Sponsor: Smith & Nephew Richards, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.5910
- Decision date: 1996-01-05
Classification & Regulation
This clearance is catalogued under FDA product code KCY and 21 CFR 878.5910, within the General, Plastic Surgery review panel as a Class I device.