Clearance Summary
UIMAT PUMP received FDA 510(k) clearance under submission number K953132, sponsored by KARL STORZ Endoscopy-America, 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 1995-08-23.
- Submission: K953132
- Applicant / Sponsor: KARL STORZ Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 1995-08-23
Classification & Regulation
This clearance is catalogued under FDA product code BTA and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.