Clearance Summary
ATS 5000 Automatic Tourniquet Instrument received FDA 510(k) clearance under submission number K202919, sponsored by Mcewen and Associates Consulting , 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 2021-05-20.
- Submission: K202919
- Applicant / Sponsor: Mcewen and Associates Consulting , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.5910
- Decision date: 2021-05-20
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.