Clearance Summary
OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP received FDA 510(k) clearance under submission number K953290, sponsored by Olympus America, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1995-10-07.
- Submission: K953290
- Applicant / Sponsor: Olympus America, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5420
- Decision date: 1995-10-07
Classification & Regulation
This clearance is catalogued under FDA product code KZD and 21 CFR 880.5420, within the General Hospital review panel as a Class I device.