Cleared Special

Bio Guard Air/Water & Suction Valves

K192059 · United States Endoscopy Group, Inc. · Gastroenterology & Urology

Sep 2019

Decision

47d

Days

Class 2

Risk

About This 510(k) Submission

K192059 is an FDA 510(k) clearance for the Bio Guard Air/Water & Suction Valves, 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 September 17, 2019, 47 days after receiving the submission on August 1, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K192059 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2019
Decision Date	September 17, 2019
Days to Decision	47 days
Submission Type	Special
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.