Compact Wearable Pump— 510(k) K230469

Substantially Equivalent

Lansinoh Laboratories

FDA 510(k) clearance K230469 for Compact Wearable Pump, Substantially Equivalent on 2023-06-30. Applicant: Lansinoh Laboratories.

Clearance details

Applicant: Lansinoh Laboratories
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2023-02-21
Decision date: 2023-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alexandria, VA, US

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.