FDA applicant

Gallini Intl., Inc.

Glen Allen, VA7 decisions1996–19970 recalls

FDA records 7 decisions for Gallini Intl., Inc. (Glen Allen, VA) from 1996 to 1997: 7 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and FCG (Biopsy Needle). Its devices cite 1 predicate, 0 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Gallini Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Gallini”

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

Gallini U.S., LLC 10 Gallini S.R.L. 1 Gallini Medical Devices, Srl 1

Gallini Intl., 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?

Other applicant names beginning “Gallini”