Naya Breast Pump System— 510(k) K160511

Substantially Equivalent

Naya Health, Inc.

FDA 510(k) clearance K160511 for Naya Breast Pump System, Substantially Equivalent on 2016-06-24. Applicant: Naya Health, Inc..

Clearance details

Applicant: Naya Health, Inc.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2016-02-24
Decision date: 2016-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, 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.