Cleared Traditional

K092429 - ENDOGATOR

K092429 is an FDA 510(k) clearance for ENDOGATOR, manufactured by Byrne Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FEQ cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K092429 · Byrne Medical, Inc. · Gastroenterology & Urology device
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Nov 2009
Decision
104d
Days
Class 2
Risk

K092429 is an FDA 510(k) clearance for the ENDOGATOR. Classified as Pump, Air, Non-manual, For Endoscope (product code FEQ), Class II - Special Controls.

Submitted by Byrne Medical, Inc. (Conroe, US). The FDA issued a Cleared decision on November 19, 2009 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Byrne Medical, Inc. devices

FDA 510(k) Submission Details - K092429

510(k) Number K092429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2009
Decision Date November 19, 2009
Days to Decision 104 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
26d faster than avg
Panel avg: 130d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FEQ Device Classification - Class 2, Special Controls

Product Code FEQ Pump, Air, Non-manual, For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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.