Clearance Summary
Bakri Essential Postpartum Balloon received FDA 510(k) clearance under submission number K223098, sponsored by Cook Incorporated. 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 2022-10-28.
- Submission: K223098
- Applicant / Sponsor: Cook Incorporated
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2022-10-28
Classification & Regulation
This clearance is catalogued under FDA product code OQY and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.