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

Name: FDA 510(k) clearance K242002
Creator: U.S. Food and Drug Administration
Published: 2024-11-22

Substantially Equivalent

Femasys, Inc.

FDA 510(k) clearance K242002 for FemVue MINI Saline-Air Device, Substantially Equivalent on 2024-11-22. Applicant: Femasys, Inc.. Device class: 2.

Clearance details

Applicant: Femasys, Inc.
Product code: Code LKF
Device class: Class 2
Regulation: 21 CFR 884.4530
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 ↗

Recent devices under product code LKF

view all

K253403 — FemVue® Controlled Saline-Air Device (FSA-300)2025-12-15
K252260 — RELIEEV HSG Catheter (HSG7FA1)2025-11-26
K240364 — RELIEEV Uterine Manipulator Injector (CUMI 5.0)2024-10-16
K241693 — FemChec Controlled Saline-Air Device (FCD-250)2024-09-06
K222798 — Rejoni Intrauterine Catheter2022-12-16

More clearances from Femasys, Inc.

view all

K231730 — FemaSeed Intratubal Insemination2023-09-22
K122658 — FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-0092012-12-20
K110993 — FEMCHEC PRESSURE MANAGEMET DEVICE2011-10-12
K110288 — FEMVUE SALINE-AIR DEVICE2011-04-28
K100662 — FEMVUE CORNUAL BALLOON CATHETER2010-04-07

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.