Cleared Special

TORRENT IRRIGATION SYSTEM

K140405 · United States Endoscopy Group, Inc. · Gastroenterology & Urology

Mar 2014

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K140405 is an FDA 510(k) clearance for the TORRENT IRRIGATION SYSTEM, a Endoscopic Irrigation/suction System (Class II — Special Controls, product code OCX), submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on March 12, 2014, 22 days after receiving the submission on February 18, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K140405 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 18, 2014
Decision Date	March 12, 2014
Days to Decision	22 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	OCX — Endoscopic Irrigation/suction System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.