Femasys Inc.
Suwanee, GA, US
FEMASYS INC. appears in FDA device records in Suwanee, GA. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Femasys Inc. between 2009 and 2025. The busiest year on record is 2011, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253403 | FemVue® Controlled Saline-Air Device (FSA-300) | LKF | Substantially Equivalent | |
| K242002 | FemVue MINI Saline-Air Device | LKF | Substantially Equivalent | |
| K241693 | FemChec Controlled Saline-Air Device (FCD-250) | LKF | Substantially Equivalent | |
| K231730 | FemaSeed Intratubal Insemination | MQF | Substantially Equivalent | |
| K122658 | FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 | PCF | Substantially Equivalent | |
| K110993 | FEMCHEC PRESSURE MANAGEMET DEVICE | LKF | Substantially Equivalent | |
| K110288 | FEMVUE SALINE-AIR DEVICE | LKF | Substantially Equivalent | |
| K100662 | FEMVUE CORNUAL BALLOON CATHETER | LKF | Substantially Equivalent | |
| K083690 | FEMVUE(TM) CATHETER SYSTEM | LKF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007800906 | 3007800906 | FEMASYS INC. | 3950 Johns Creek Court, Suwanee, GA 30024 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain