Cleared Special

K140405 - TORRENT IRRIGATION SYSTEM

K140405 is an FDA 510(k) clearance for TORRENT IRRIGATION SYSTEM, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Special 510(k) pathway after a 22-day FDA review.

K140405 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
22d
Days
Class 2
Risk

K140405 is an FDA 510(k) clearance for the TORRENT IRRIGATION SYSTEM. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on March 12, 2014 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K140405

510(k) Number K140405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 131d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

OCX Device Classification - Class 2, Special Controls

Product Code OCX Endoscopic Irrigation/suction System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCX Endoscopic Irrigation/suction System

All 90
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K140405.
ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM
K140753 · Medivators · Jul 2014
US ENDOSCOPY DISTAL ATTACHMENT CAP
K140315 · United States Endoscopy Group, Inc. · Apr 2014
SEAL SINGLE-USE BIOPSY VALVE
K133734 · Endochoice, Inc. · Mar 2014
MEDLINE BIOPSY VALVE
K131426 · Medline Industries, Inc. · Feb 2014
SEAL BIOPSY VALVE - REUSABLE
K132776 · Endochoice, Inc. · Dec 2013
SCOPEVALET DISPOSABLE BIOPSY VALVE
K122417 · The Ruhof Corp. · May 2013
K140405 · TORRENT IRRIGATION SYSTEM
Download PDF FDA Summary United States Endosco…