FDA applicant

Gastrotech, Inc.

Independence, OH5 decisions1986–19890 recalls

FDA records 5 decisions for Gastrotech, Inc. (Independence, OH) from 1986 to 1989: 5 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and FED (Endoscopic Access Overtube…). 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 Gastrotech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gastrotech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Gastrotech, Inc.

Which product codes does it file in?

What has FDA decided for it lately?