# Femasys, Inc.

- Location (FDA's records): Suwanee, GA
- FDA decisions: 9 (2009–2025): 9 510(k) clearances
- Product codes: LKF (7), PCF (1), MQF (1)
- Predicates its devices cite: 10 (4 its own); citations of its devices by later devices: 8 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ackrad Laboratories: 2 (https://510kreport.com/company/ackrad-laboratories)
- Femspec LLC: 1 (https://510kreport.com/company/femspec)
- Cook Ob/Gyn: 1 (https://510kreport.com/company/cook-ob-gyn)
- Shiley, Inc.: 1 (https://510kreport.com/company/shiley)
- Maquet Cardiovascular, LLC: 1 (https://510kreport.com/company/maquet-cardiovascular)

## Firms that cite its devices most
- Crossbay Medical, Inc.: 2 (https://510kreport.com/company/crossbay-medical)
- CooperSurgical, Inc.: 1 (https://510kreport.com/company/coopersurgical)
- Catheter Research, Inc.: 1 (https://510kreport.com/company/catheter-research)

## Its most-cited devices
- K110288: Femvue Saline-Air Device (2011), cited by 4
- K083690: Femvue (TM) Catheter System (2009), cited by 3
- K241693: FemChec Controlled Saline-Air Device (FCD-250) (2024), cited by 1

## Recent decisions
- K253403: FemVue® Controlled Saline-Air Device (FSA-300) (Dec 15, 2025)
- K242002: FemVue MINI Saline-Air Device (Nov 22, 2024)
- K241693: FemChec Controlled Saline-Air Device (FCD-250) (Sep 6, 2024)
- K231730: FemaSeed Intratubal Insemination (Sep 22, 2023)
- K122658: Femcerv Endocervical Sampler Model 3 Sizes: Ref FCV-013, Ref FCV-011, Ref FCV-009 (Dec 20, 2012)
- K110993: Femchec Pressure Managemet Device (Oct 12, 2011)
- K110288: Femvue Saline-Air Device (Apr 28, 2011)
- K100662: Femvue Cornual Balloon Catheter (Apr 7, 2010)

Source page: https://510kreport.com/company/femasys