Clearance Summary
SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE received FDA 510(k) clearance under submission number K063688, sponsored by The Anspach Effort, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2007-01-16.
- Submission: K063688
- Applicant / Sponsor: The Anspach Effort, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 2007-01-16
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.