Cleared Traditional

K033695 - IRRIGATION CHANNEL TUBING

K033695 is an FDA 510(k) clearance for IRRIGATION CHANNEL TUBING, manufactured by Byrne Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K033695 · Byrne Medical, Inc. · Gastroenterology & Urology device
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Dec 2003
Decision
28d
Days
Class 2
Risk

K033695 is an FDA 510(k) clearance for the IRRIGATION CHANNEL TUBING, MODEL 100135. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Byrne Medical, Inc. (Houston, US). The FDA issued a Cleared decision on December 23, 2003 after a review of 28 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 Byrne Medical, Inc. devices

FDA 510(k) Submission Details - K033695

510(k) Number K033695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2003
Decision Date December 23, 2003
Days to Decision 28 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 66
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K033695.
ERBEFLO 2 DISPOSABLE TUBING SYSTEM
K103235 · Erbe USA, Inc. · Dec 2010
IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140
K092461 · United States Endoscopy Group, Inc. · Nov 2009
ENDOMAT LC PUMP, MODEL 20 3303 20
K031457 · KARL STORZ Endoscopy-America, Inc. · Apr 2004
KSEA QUADRO SWITCH
K021776 · Karl Storz Endoscopy · Aug 2002
HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
K993778 · Northgate Technologies, Inc. · Jan 2000
ENDIUS SUCTION/IRRIGATION INSTRUMENT
K992535 · Endius, Inc. · Sep 1999