Annabella Double Breast Pump (ADO-US23-1000)— 510(k) K241506

Substantially Equivalent

Annabella Tech

FDA 510(k) clearance K241506 for Annabella Double Breast Pump (ADO-US23-1000), Substantially Equivalent on 2024-06-27. Applicant: Annabella Tech.

Clearance details

Applicant: Annabella Tech
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2024-05-28
Decision date: 2024-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Kfar Saba, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.