Cleared Special

ALIEN RX MICRO CANNULA, MODEL 4530

K010993 · Boston Scientific Corp · Gastroenterology & Urology
Apr 2001
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K010993 is an FDA 510(k) clearance for the ALIEN RX MICRO CANNULA, MODEL 4530, a Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula (Class II — Special Controls, product code ODD), submitted by Boston Scientific Corp (Natick, US). The FDA issued a Cleared decision on April 30, 2001, 27 days after receiving the submission on April 3, 2001. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K010993 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2001
Decision Date April 30, 2001
Days to Decision 27 days
Submission Type Special
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.

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