Freestyle Flex— 510(k) K191653

Substantially Equivalent

Medela AG

FDA 510(k) clearance K191653 for Freestyle Flex, Substantially Equivalent on 2019-10-17. Applicant: Medela AG.

Clearance details

Applicant: Medela AG
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2019-06-20
Decision date: 2019-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baar Zug, 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.