FDA applicant

Gynesonics, Inc.

Redwood City, CA8 decisions2006–20250 recalls

FDA records 8 decisions for Gynesonics, Inc. (Redwood City, CA) from 2006 to 2025: 8 510(k) clearances. Most are in product codes KNF (Coagulator-Cutter, Endoscopic, Unipolar (And…) and ITX (Transducer, Ultrasonic, Diagnostic). Its devices cite 11 predicates, 7 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 Gynesonics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007high 1 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gynesonics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gynesonics, 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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Gynesonics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?