Willow Wearable Breast Pump 2.0— 510(k) K191577

Substantially Equivalent

Exploramed Nc7, Inc.

FDA 510(k) clearance K191577 for Willow Wearable Breast Pump 2.0, Substantially Equivalent on 2019-09-06. Applicant: Exploramed Nc7, Inc..

Clearance details

Applicant: Exploramed Nc7, Inc.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2019-06-14
Decision date: 2019-09-06
Decision: Substantially Equivalent
Clearance type: Special
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.