Willow Generation 3 Breast Pump— 510(k) K230570

Substantially Equivalent

Willow Innovations, Inc.

FDA 510(k) clearance K230570 for Willow Generation 3 Breast Pump, Substantially Equivalent on 2023-10-16. Applicant: Willow Innovations, Inc..

Clearance details

Applicant: Willow Innovations, Inc.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2023-03-01
Decision date: 2023-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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.