Cleared Special

DISPOSABLE BENDING CANNULA PR-233Q

K011149 · The Olympus Optical Co. · Gastroenterology & Urology
May 2001
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K011149 is an FDA 510(k) clearance for the DISPOSABLE BENDING CANNULA PR-233Q, a Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula (Class II — Special Controls, product code ODD), submitted by The Olympus Optical Co. (Melville, US). The FDA issued a Cleared decision on May 15, 2001, 29 days after receiving the submission on April 16, 2001. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K011149 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2001
Decision Date May 15, 2001
Days to Decision 29 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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