Cleared Traditional

URETEROMAT 4400 (K915751) - FDA 510(k) Clearance

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

K915751 · F.M. Wiest USA, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
123d
Days
Class 2
Risk

K915751 is an FDA 510(k) clearance for the URETEROMAT 4400. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by F.M. Wiest USA, Inc. (Oradell, US). The FDA issued a Cleared decision on April 24, 1992 after a review of 123 days - within the typical 510(k) review window.

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 F.M. Wiest USA, Inc. devices

Submission Details

510(k) Number K915751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1991
Decision Date April 24, 1992
Days to Decision 123 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 130d · This submission: 123d
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 21
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K915751.
UROLOGICAL BALLOON DILATATION CATHETER
K935379 · Boston Scientific Corp · Feb 1994
MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER
K933011 · Boston Scientific Corp · Feb 1994
UROLOGICAL BALLOON DILATATION CATHETER
K920946 · Boston Scientific Corp · Jul 1992
CATHETER, URETERAL DILATOR
K914617 · Boston Scientific Corp · Dec 1991
URS-HYDRO-DILATOR MODEL NUMBER 2164.00
K912331 · Richard Wolf Medical Instruments Corp. · Oct 1991
URETERAL BALLOON DILATATION CATHETER
K903813 · Boston Scientific Corp · Nov 1990