Clearance Summary
Powered Breast Pump (Models 7V and 7X) received FDA 510(k) clearance under submission number K211016, sponsored by Haenim Co., Ltd.. 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 2022-06-29.
- Submission: K211016
- Applicant / Sponsor: Haenim Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2022-06-29
Classification & Regulation
This clearance is catalogued under FDA product code HGX and 21 CFR 884.5160, within the Obstetrics/Gynecology review panel as a Class II device.