Cleared Traditional

K903994 - URETEROPYELOGRAM CATH FOR RETROGRADE DY...

K903994 is an FDA 510(k) clearance for URETEROPYELOGRAM CATH FOR RETROGRADE DY..., manufactured by Applied Urology, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGF cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K903994 · Applied Urology, Inc. · Gastroenterology & Urology device
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Oct 1990
Decision
51d
Days
Class 2
Risk

K903994 is an FDA 510(k) clearance for the URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION. Classified as Catheter, Ureteral Disposable (x-ray) (product code FGF), Class II - Special Controls.

Submitted by Applied Urology, Inc. (Launa Hills, US). The FDA issued a Cleared decision on October 19, 1990 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Applied Urology, Inc. devices

FDA 510(k) Submission Details - K903994

510(k) Number K903994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1990
Decision Date October 19, 1990
Days to Decision 51 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
79d faster than avg
Panel avg: 130d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGF Device Classification - Class 2, Special Controls

Product Code FGF Catheter, Ureteral Disposable (x-ray)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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.