Clearance Summary
ACUFEX ROTATOR CUFF FIXATION BUTTON received FDA 510(k) clearance under submission number K941740, sponsored by Acufex Microsurgical, 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 1995-06-30.
- Submission: K941740
- Applicant / Sponsor: Acufex Microsurgical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4930
- Decision date: 1995-06-30
Classification & Regulation
This clearance is catalogued under FDA product code KGS and 21 CFR 878.4930, within the General, Plastic Surgery review panel as a Class I device.