Cleared Traditional

K902124 - DOWD CATHETER

K902124 is the FDA 510(k) clearance for DOWD CATHETER by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FAH) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K902124 · Boston Scientific Corp · Gastroenterology & Urology device
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Aug 1990
Decision
90d
Days
Class 2
Risk

K902124 is an FDA 510(k) clearance for the DOWD CATHETER. Classified as Dilator, Urethral, Mechanical (product code FAH), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on August 9, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5520 - 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 K902124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1990
Decision Date August 09, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAH Dilator, Urethral, Mechanical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5520
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.