Clearance Summary
uVue HSG/SHG Catheter received FDA 510(k) clearance under submission number K160217, sponsored by Cook Incorporated. 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 2016-10-06.
- Submission: K160217
- Applicant / Sponsor: Cook Incorporated
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2016-10-06
Classification & Regulation
This clearance is catalogued under FDA product code LKF and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.