FDA applicant

Surgitek Medical Engineering Corp.

Racine, WI11 decisions1990–19920 recalls

FDA records 11 decisions for Surgitek Medical Engineering Corp. (Racine, WI) from 1990 to 1992: 11 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and FDX (Endoscopic Cytology Brush). 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 Surgitek Medical Engineering Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Surgitek Medical Engineering Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Surgitek”

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

Surgitek 29

Surgitek Medical Engineering Corp.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Surgitek”