FDA applicant

Gynopharma, Inc.

Princeton, NJ2 decisions1991–19910 recalls

FDA records 2 decisions for Gynopharma, Inc. (Princeton, NJ) in 1991: 2 510(k) clearances. Most are in product codes HFF (Aspirator, Endometrial) and HIT (Tester, Color Vision). 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 Gynopharma, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gynopharma, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Gynopharma, Inc.

Which product codes does it file in?

What has FDA decided for it lately?