Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump— 510(k) K182749

Substantially Equivalent

Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.

FDA 510(k) clearance K182749 for Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump, Substantially Equivalent on 2019-06-12. Applicant: Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd..

Clearance details

Applicant: Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.
Product code: 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

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.