K241506

Substantially Equivalent

Annabella Double Breast Pump (ADO-US23-1000)

Applicant: Annabella Tech
Product 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

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.