K182749

Substantially Equivalent

Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump

Applicant: Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.
Product code: HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2018-09-28
Decision date: 2019-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cigli, TR

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.