Cleared Traditional

K092461 - IRRIGATION PUMP

K092461 is the FDA 510(k) clearance for IRRIGATION PUMP by United States Endoscopy Group, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCX) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K092461 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Nov 2009
Decision
86d
Days
Class 2
Risk

K092461 is an FDA 510(k) clearance for the IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140. 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 November 5, 2009 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K092461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2009
Decision Date November 05, 2009
Days to Decision 86 days
Submission Type Traditional
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
44d faster than avg
Panel avg: 130d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 53
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K092461.
MEDLINE BIOPSY VALVE
K131426 · Medline Industries, Inc. · Feb 2014
GATEWAY ADVANAGE Y-ADAPTER
K130909 · Boston Scientific Corp · May 2013
IRRIGATION SYSTEM
K103239 · United States Endoscopy Group, Inc. · Dec 2010
ENDOMAT LC PUMP, MODEL 20 3303 20
K031457 · KARL STORZ Endoscopy-America, Inc. · Apr 2004
HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
K993778 · Northgate Technologies, Inc. · Jan 2000
CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)
K964196 · Northgate Technologies, Inc. · Dec 1996