The Pump by Babyation— 510(k) K173699

Substantially Equivalent

Babyation, LLC

FDA 510(k) clearance K173699 for The Pump by Babyation, Substantially Equivalent on 2018-04-04. Applicant: Babyation, LLC.

Clearance details

Applicant: Babyation, LLC
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2017-12-04
Decision date: 2018-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, 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.