FDA applicant

Gynescope Corp.

Willoughby, OH9 decisions1990–19900 recalls

FDA records 9 decisions for Gynescope Corp. (Willoughby, OH) in 1990: 9 510(k) clearances. Most are in product codes HET (Laparoscope, Gynecologic (And Accessories)) and HFB (Forceps, Biopsy, Gynecological). 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 Gynescope Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gynescope Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Gynescope Corp.’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

Gynescope Corp.

Which product codes does it file in?

What has FDA decided for it lately?