510(k) Report

FDA applicant

Cortek Endoscopy, Inc.

Palatine, IL5 decisions2000–20000 recalls

FDA records 5 decisions for Cortek Endoscopy, Inc. (Palatine, IL) in 2000: 5 510(k) clearances. Most are in product codes HRX (Arthroscope) and HET (Laparoscope, Gynecologic (And Accessories)). 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 Cortek Endoscopy, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cortek Endoscopy, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cortek Endoscopy, Inc.’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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