Cleared Traditional

BioGuard Air/Water Valve, BioGuard Suction Valve

K151345 · United States Endoscopy Group, Inc. · Gastroenterology & Urology

Aug 2015

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K151345 is an FDA 510(k) clearance for the BioGuard Air/Water Valve, BioGuard Suction Valve, a Endoscope Channel Accessory (Class II — Special Controls, product code ODC), submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on August 25, 2015, 98 days after receiving the submission on May 19, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K151345 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 2015
Decision Date	August 25, 2015
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

Device Classification

Product Code	ODC — Endoscope Channel Accessory
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Give The Endoscope Channel Additional Or Improved Functionality.