Cleared Traditional

BONASTENT BILIARY

K140760 · Endochoice, Inc. · Gastroenterology & Urology
Jun 2014
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K140760 is an FDA 510(k) clearance for the BONASTENT BILIARY, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Endochoice, Inc. (Toronto, CA). The FDA issued a Cleared decision on June 16, 2014, 82 days after receiving the submission on March 26, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.

Submission Details

510(k) Number K140760 FDA.gov
FDA Decision Cleared SESU
Date Received March 26, 2014
Decision Date June 16, 2014
Days to Decision 82 days
Submission Type Traditional
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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