Cleared Traditional

K912331 - URS-HYDRO-DILATOR MODEL NUMBER 2164.00

K912331 is the FDA 510(k) clearance for URS-HYDRO-DILATOR MODEL NUMBER 2164.00 by Richard Wolf Medical Instruments Corp.. It is a Class 2 Gastroenterology & Urology device (product code EZN) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

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.

View all Richard Wolf Medical Instruments Corp. devices

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - EZN Dilator, Catheter, Ureteral

All 43
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K912331.
UROLOGICAL BALLOON DILATATION CATHETER
K920946 · Boston Scientific Corp · Jul 1992
ACCENT DG BALLOON URTERAL DILATOR SET, 10CM
K915392 · Cook Urological, Inc. · Mar 1992
CATHETER, URETERAL DILATOR
K914617 · Boston Scientific Corp · Dec 1991
ACCENT DG BALLOON URETERAL DILATOR SET
K905375 · Cook Urological, Inc. · Apr 1991
URETERAL BALLOON DILATATION CATHETER
K903813 · Boston Scientific Corp · Nov 1990
BALLOON DILATION CATHETER
K896448 · Cook Ob/Gyn · Mar 1990