510(k) Report

FDA applicant

Cape Tech Medical Products

Falmouth, MA3 decisions1992–19930 recalls

FDA records 3 decisions for Cape Tech Medical Products (Falmouth, MA) from 1992 to 1993: 3 510(k) clearances. Most are in product codes KNQ (Dilator, Esophageal) and LQR (Dislodger, Stone, Biliary). 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 Cape Tech Medical Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cape Tech Medical Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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