Clearance Summary
YASARGIL SUCTION TUBE - SMALL received FDA 510(k) clearance under submission number K760745, sponsored by Codman & Shurtleff, 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 1976-11-01.
- Submission: K760745
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4680
- Decision date: 1976-11-01
Classification & Regulation
This clearance is catalogued under FDA product code GCY and 21 CFR 878.4680, within the General, Plastic Surgery review panel as a Class I device.