GENTLE EXPRESSIONS ELECTRIC BREAST PUMP— 510(k) K890588

Substantially Equivalent

Healthteam

FDA 510(k) clearance K890588 for GENTLE EXPRESSIONS ELECTRIC BREAST PUMP, Substantially Equivalent on 1989-05-16. Applicant: Healthteam.

Clearance details

Applicant: Healthteam
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 1989-02-06
Decision date: 1989-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: S. Plainfield, NJ, 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.