Clearance Summary
COOK ULTRA QUIET VACUUM PUMP & REGULATOR received FDA 510(k) clearance under submission number K992070, sponsored by Cook Urological, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1999-10-27.
- Submission: K992070
- Applicant / Sponsor: Cook Urological, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6120
- Decision date: 1999-10-27
Classification & Regulation
This clearance is catalogued under FDA product code MQG and 21 CFR 884.6120, within the Obstetrics/Gynecology review panel as a Class II device.