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510(k) K241506

Annabella Double Breast Pump (ADO-US23-1000) by Annabella Tech — Product Code HGX

K241506 is an FDA 510(k) premarket notification submitted by Annabella Tech for the device "Annabella Double Breast Pump (ADO-US23-1000)". The FDA issued a decision of Substantially Equivalent on June 27, 2024. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2024
Date Received
May 28, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type

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  • K260956 — Spectra Platinum Mini (June 4, 2026)
  • K254300 — eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T600 (May 29, 2026)
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FDA data resources