Cleared Special

Howell D.A.S.H Extraction Balloon with Multiple Sizing

K173659 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology

Jul 2018

Decision

219d

Days

Class 2

Risk

About This 510(k) Submission

K173659 is an FDA 510(k) clearance for the Howell D.A.S.H Extraction Balloon with Multiple Sizing, a Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (Class II — Special Controls, product code GCA), submitted by Wilson-Cook Medical, Inc. (Winstrom-Salem, US). The FDA issued a Cleared decision on July 6, 2018, 219 days after receiving the submission on November 29, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.

Submission Details

510(k) Number	K173659 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 2017
Decision Date	July 06, 2018
Days to Decision	219 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	GCA — Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5010