Clearance Summary
Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201) received FDA 510(k) clearance under submission number K223329, sponsored by Guangzhou Yongyi Industrial 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 2023-05-26.
- Submission: K223329
- Applicant / Sponsor: Guangzhou Yongyi Industrial Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2023-05-26
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.