Clearance Summary
ANSPACH MENISECTOMY KNIFE received FDA 510(k) clearance under submission number K803178, sponsored by The Anspach Effort, 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 1981-02-13.
- Submission: K803178
- Applicant / Sponsor: The Anspach Effort, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1981-02-13
Classification & Regulation
This clearance is catalogued under FDA product code FZS and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.