Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Wilson-Cook Medical, Inc.

FDA 510(k) & PMA Approved Devices — 32 products

Total Devices32
Categories19
Latest FDA decision2026-06-02
TypeNumberDevice NameCodeDateActions
510(k) K171989 Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal CatheterODD2018-03-20 View
510(k) K163377 Captura Disposable Bronchoscope Biopsy ForcepsEOQ2018-02-21 View
510(k) K171573 Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushFDX2017-12-29 View
510(k) K171548 Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterFGE2017-10-13 View
510(k) K170292 Tri-Ex Extraction Balloon With Multiple SizingGCA2017-09-20 View
510(k) K171596 ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound NeedleFCG2017-08-04 View
510(k) K171223 Quantum TTC Biliary Balloon DilatorFGE2017-06-16 View
510(k) K160890 Howell Biliary Introducer NeedleFCG2017-06-14 View
510(k) K162142 Accessory Irrigation AdapterODC2017-04-27 View
510(k) K153763 Howell Biliary Aspiration NeedleFCK2017-04-06 View
510(k) K160170 Lehman Manometry CatheterFFX2016-06-20 View
510(k) K161203 Soehendra Stent RetrieverFGE2016-05-04 View

Page 2 of 2

↑