Clearance Summary
Annabella Double Breast Pump (ADO-US23-1000) received FDA 510(k) clearance under submission number K241506, sponsored by Annabella Tech. 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 2024-06-27.
- Submission: K241506
- Applicant / Sponsor: Annabella Tech
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2024-06-27
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.