Clearance Summary
IUR FLUID MANAGEMENT SYSTEM received FDA 510(k) clearance under submission number K031616, sponsored by W.O.M. World of Medicine AG. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2003-08-13.
- Submission: K031616
- Applicant / Sponsor: W.O.M. World of Medicine AG
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1700
- Decision date: 2003-08-13
Classification & Regulation
This clearance is catalogued under FDA product code HIG and 21 CFR 884.1700, within the Obstetrics/Gynecology review panel as a Class II device.