Cleared Traditional

BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138

K070420 · United States Endoscopy Group, Inc. · Gastroenterology & Urology

Mar 2007

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K070420 is an FDA 510(k) clearance for the BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138, a Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula (Class II — Special Controls, product code ODD), submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on March 19, 2007, 27 days after receiving the submission on February 20, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K070420 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 20, 2007
Decision Date	March 19, 2007
Days to Decision	27 days
Submission Type	Traditional
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.