FDA applicant
Cortek Endoscopy, Inc.
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
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.
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.
See the 510(k) Report