Clearance Summary
MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 received FDA 510(k) clearance under submission number K071140, sponsored by Top Spins, 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 2007-06-07.
- Submission: K071140
- Applicant / Sponsor: Top Spins, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.5910
- Decision date: 2007-06-07
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.