FDA applicant

Gyne-Tech Instrument Corp.

Burbank, CA3 decisions1992–19960 recalls

FDA records 3 decisions for Gyne-Tech Instrument Corp. (Burbank, CA) from 1992 to 1996: 3 510(k) clearances. Most are in product codes HGI (Electrocautery, Gynecologic (And Accessories)) and GEX (Powered Laser Surgical Instrument). 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, general and plastic surgery panel, where it files most

How often FDA has decided Gyne-Tech Instrument Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gyne-Tech Instrument Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Gyne-Tech Instrument Corp.’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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Other applicant names beginning “Gyne-Tech”

FDA records each applicant name separately; these may or may not be the same firm.

Gyne Ideas, Ltd. 1

Gyne-Tech Instrument Corp.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Gyne-Tech”