Cleared Traditional

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 Catheter

K171989 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology

Mar 2018

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K171989 is an FDA 510(k) clearance for the 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 Catheter, a Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula (Class II — Special Controls, product code ODD), submitted by Wilson-Cook Medical, Inc. (Winstrom-Salem, US). The FDA issued a Cleared decision on March 20, 2018, 260 days after receiving the submission on July 3, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K171989 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2017
Decision Date	March 20, 2018
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	ODD — Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Identify Stones, Tumors, Or Narrowing In The Biliary Tree.