Clearance Summary
SURGIPUMP received FDA 510(k) clearance under submission number K935763, sponsored by W.O.M. World of Medicine GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1994-04-21.
- Submission: K935763
- Applicant / Sponsor: W.O.M. World of Medicine GmbH
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1800
- Decision date: 1994-04-21
Classification & Regulation
This clearance is catalogued under FDA product code DQI and 21 CFR 870.1800, within the Cardiovascular review panel as a Class II device.