FEMASYS INC.

FDA Device Registration & Listing · Suwanee, GA, US · Registration 3007800906

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007800906
FEI Number
3007800906
Entity Name
FEMASYS INC.
City/State/Country
Suwanee, GA, US
Establishment Address
3950 Johns Creek Court, Ste 100, Suwanee, GA 30024, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Femasys Inc. (Owner Number: 10030021)
Owner / Operator Contact Address
3950 Johns Creek Court, Suite 100, Suwanee, GA 30024, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K122658
PMA Number
N/A

All Registered Proprietary Names

FemVue FemChec Controlled Saline-Air Device FemSperm Analyzer FemCath Cornual Balloon Catheter VariLock Balloon Inflation Syringe StopLock Balloon Inflation Syringe FemCerv¿

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2011-11-07
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2024-09-11
POV Semen Analysis Device Hematology Class 2 864.5220 2026-01-26
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2010-04-14
PTM Syringe, Balloon Inflation, Exempt Cardiovascular Class 2 870.1650 2023-05-15
PCF Sampler, Endocervical Obstetrics/Gynecology Class 2 884.1050 2013-01-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Femasys Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007800906. Last updated year: 2026. Please use registration number 3007800906 when referencing this establishment in official correspondence.
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