Clearance Summary
Double Lumen Ovum Aspiration Needles received FDA 510(k) clearance under submission number K171611, sponsored by William A. Cook Australia Pty. , Ltd.. 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 2017-12-15.
- Submission: K171611
- Applicant / Sponsor: William A. Cook Australia Pty. , Ltd.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6100
- Decision date: 2017-12-15
Classification & Regulation
This clearance is catalogued under FDA product code MQE and 21 CFR 884.6100, within the Obstetrics/Gynecology review panel as a Class II device.