Philips Avent Comfort Single/Twin Electric Breast Pump— 510(k) K161532

Substantially Equivalent

Philips Consumer Lifestyle - Innovation Site Eindhoven

FDA 510(k) clearance K161532 for Philips Avent Comfort Single/Twin Electric Breast Pump, Substantially Equivalent on 2016-08-29. Applicant: Philips Consumer Lifestyle - Innovation Site Eindhoven.

Clearance details

Applicant: Philips Consumer Lifestyle - Innovation Site Eindhoven
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2016-06-02
Decision date: 2016-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eindhoven, NL

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.