Cleared Traditional

K060962 - ENDOGATOR ENDOSCOPY IRRIGATION PUMP

K060962 is an FDA 510(k) clearance for ENDOGATOR ENDOSCOPY IRRIGATION PUMP, 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 12-day FDA review.

K060962 · Byrne Medical, Inc. · Gastroenterology & Urology device
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Apr 2006
Decision
12d
Days
Class 2
Risk

K060962 is an FDA 510(k) clearance for the ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100. 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 April 19, 2006 after a review of 12 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 - K060962

510(k) Number K060962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2006
Decision Date April 19, 2006
Days to Decision 12 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
118d faster than avg
Panel avg: 130d · This submission: 12d
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 K060962.
IRRIGATION SYSTEM
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