Clearance Summary
ACUFEX STERILE DRILLS received FDA 510(k) clearance under submission number K931837, 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 1994-01-07.
- Submission: K931837
- Applicant / Sponsor: Acufex Microsurgical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1994-01-07
Classification & Regulation
This clearance is catalogued under FDA product code HWE and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.