Cleared Traditional

K903036 - P.R.G. GUIDEWIRE PLACEMENT SYSTEM

K903036 is the FDA 510(k) clearance for P.R.G. GUIDEWIRE PLACEMENT SYSTEM by Applied Medical Technologies. It is a Class 2 Gastroenterology & Urology device (product code KGC) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K903036 · Applied Medical Technologies · Gastroenterology & Urology device
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Nov 1990
Decision
131d
Days
Class 2
Risk

K903036 is an FDA 510(k) clearance for the P.R.G. GUIDEWIRE PLACEMENT SYSTEM. Classified as Tube, Gastro-enterostomy (product code KGC), Class II - Special Controls.

Submitted by Applied Medical Technologies (Independence, US). The FDA issued a Cleared decision on November 19, 1990 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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.

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Submission Details

510(k) Number K903036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received July 11, 1990
Decision Date November 19, 1990
Days to Decision 131 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 130d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KGC Tube, Gastro-enterostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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.