Cleared Special

AngioDynamics Total Abscession Biliary Drainage Catheter

K170743 · AngioDynamics, Inc. · Gastroenterology & Urology
Mar 2017
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K170743 is an FDA 510(k) clearance for the AngioDynamics Total Abscession Biliary Drainage Catheter, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on March 30, 2017, 20 days after receiving the submission on March 10, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.

Submission Details

510(k) Number K170743 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2017
Decision Date March 30, 2017
Days to Decision 20 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FGE — Stents, Drains And Dilators For The Biliary Ducts
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5010

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