FemVue MINI Saline-Air Device— 510(k) K242002

Substantially Equivalent

Femasys, Inc.

FDA 510(k) clearance K242002 for FemVue MINI Saline-Air Device, Substantially Equivalent on 2024-11-22. Applicant: Femasys, Inc..

Clearance details

Applicant: Femasys, Inc.
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2024-07-09
Decision date: 2024-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwanee, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LKF

product code LKF

Malfunction: 643
Other: 2
Total: 645

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.