Clearance Summary
Cook Silicone Balloon HSG Catheter received FDA 510(k) clearance under submission number K180291, 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 2018-10-26.
- Submission: K180291
- Applicant / Sponsor: Cook Incorporated
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2018-10-26
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.