FDA applicant

Femasys, Inc.

Suwanee, GA9 decisions2009–20250 recalls

FDA records 9 decisions for Femasys, Inc. (Suwanee, GA) from 2009 to 2025: 9 510(k) clearances. Most are in product codes LKF (Cannula, Manipulator/Injector, Uterine) and PCF (Sampler, Endocervical). Its devices cite 10 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Femasys, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2009high 2 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Femasys, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Femasys, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Femasys, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?