Evolve Breast Pump— 510(k) K190465

Substantially Equivalent

Hygeia II Medical Group, Inc.

FDA 510(k) clearance K190465 for Evolve Breast Pump, Substantially Equivalent on 2019-10-18. Applicant: Hygeia II Medical Group, Inc..

Clearance details

Applicant: Hygeia II Medical Group, Inc.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2019-02-26
Decision date: 2019-10-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Carlsbad, 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.