Wearable breast pump— 510(k) K221598

Substantially Equivalent

Mayborn (Uk) Limited

FDA 510(k) clearance K221598 for Wearable breast pump, Substantially Equivalent on 2022-12-09. Applicant: Mayborn (Uk) Limited.

Clearance details

Applicant: Mayborn (Uk) Limited
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2022-06-02
Decision date: 2022-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newcastle Upon Tyne,, GB

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.