Cleared Traditional

K912331 - URS-HYDRO-DILATOR MODEL NUMBER 2164.00

K912331 is an FDA 510(k) clearance for URS-HYDRO-DILATOR MODEL NUMBER 2164.00, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Gastroenterology & Urology device with 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

FDA 510(k) Submission Details - K912331

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
28d slower than avg
Panel avg: 131d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZN Device Classification - Class 2, Special Controls

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 50
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K912331.
UROLOGICAL BALLOON DILATATION CATHETER
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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
NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY
K905181 · Meadox Surgimed, Inc. · Mar 1991
MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY
K904983 · Meadox Surgimed, Inc. · Jan 1991