Data / Medical devices / United States / Femasys Inc.

Femasys Inc.: FDA-registered device maker in Suwanee, GA, United States, 7 510(k) clearances

Name: Femasys Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Femasys Inc. is registered with the FDA (registration 3007800906) in Suwanee, GA, United States. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated May 2, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007800906
Address: 3950 Johns Creek Court Ste 100, Suwanee, GA, United States, 30024
Owner or operator: Femasys Inc. (10030021)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed: April 14, 2010
Registered through: 2026
Brand names listed: FemCath Cornual Balloon Catheter, FemCerv¿, FemChec Controlled Saline-Air Device, FemSperm, FemSperm Analyzer, FemVue, FemaSeed Intratubal Insemination, StopLock Balloon Inflation Syringe and more

Devices it lists

Device	Product code	Class	Role	Source
Cannula, Manipulator/Injector, Uterine	LKF	2	Manufacturer	accessdata.fda.gov
Catheter, Assisted Reproduction	MQF	2	Manufacturer	accessdata.fda.gov
Media, Reproductive	MQL	2	Repackager or relabeler	accessdata.fda.gov
Sampler, Endocervical	PCF	2	Manufacturer	accessdata.fda.gov
Semen Analysis Device	POV	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Balloon Inflation, Exempt	PTM	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 2, 2025	K243114	SQA-iOw Sperm Quality Analyzer	POV	Substantially Equivalent	Medical Electronic Systems , Ltd.	accessdata.fda.gov
September 6, 2024	K241693	FemChec Controlled Saline-Air Device (FCD-250)	LKF	Substantially Equivalent	Femasys, Inc.	accessdata.fda.gov
September 22, 2023	K231730	FemaSeed Intratubal Insemination	MQF	Substantially Equivalent	Femasys, Inc.	accessdata.fda.gov
December 20, 2012	K122658	FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009	PCF	Substantially Equivalent	Femasys, Inc.	accessdata.fda.gov
April 28, 2011	K110288	FEMVUE SALINE-AIR DEVICE	LKF	Substantially Equivalent	Femasys, Inc.	accessdata.fda.gov
April 7, 2010	K100662	FEMVUE CORNUAL BALLOON CATHETER	LKF	Substantially Equivalent	Femasys, Inc.	accessdata.fda.gov
December 26, 2002	K023222	ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12	MQL	Substantially Equivalent	Invitrocare, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.