Cleared Traditional

K912331 - URS-HYDRO-DILATOR MODEL NUMBER 2164.00 (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K912331 · Richard Wolf Medical Instruments Corp. · Gastroenterology & Urology device
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Oct 1991
Decision
159d
Days
Class 2
Risk

K912331 is an FDA 510(k) clearance for the URS-HYDRO-DILATOR MODEL NUMBER 2164.00. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Rosemont, US). The FDA issued a Cleared decision on October 30, 1991 after a review of 159 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5470 - 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 K912331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1991
Decision Date October 30, 1991
Days to Decision 159 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 130d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZN Dilator, Catheter, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5470
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.