Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty— 510(k) K150499

Substantially Equivalent

Medela AG

FDA 510(k) clearance K150499 for Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty, Substantially Equivalent on 2015-04-21. Applicant: Medela AG.

Clearance details

Applicant: Medela AG
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2015-02-26
Decision date: 2015-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baar, CH

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.