Cleared Traditional

K894925 - AMCATH URETERAL DILATORS MODELS 7100

K894925 is the FDA 510(k) clearance for AMCATH URETERAL DILATORS MODELS 7100 by Intec Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code EZN) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K894925 · Intec Medical, Inc. · Gastroenterology & Urology device
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Dec 1989
Decision
133d
Days
Class 2
Risk

K894925 is an FDA 510(k) clearance for the AMCATH URETERAL DILATORS MODELS 7100,7110,7120. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Intec Medical, Inc. (Danielson, US). The FDA issued a Cleared decision on December 13, 1989 after a review of 133 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 Intec Medical, Inc. devices

Submission Details

510(k) Number K894925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1989
Decision Date December 13, 1989
Days to Decision 133 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 130d · This submission: 133d
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 34
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K894925.
URS-HYDRO-DILATOR MODEL NUMBER 2164.00
K912331 · Richard Wolf Medical Instruments Corp. · Oct 1991
ACCENT DG BALLOON URETERAL DILATOR SET
K905375 · Cook Urological, Inc. · Apr 1991
URETERAL BALLOON DILATATION CATHETER
K903813 · Boston Scientific Corp · Nov 1990
URETERAL DILATOR
K852324 · American Edwards Laboratories · Aug 1985
URETERAL DILATOR/SHEATH SET
K852793 · American Edwards Laboratories · Aug 1985
DIAFLEX NEPHROSTOMY BALLOON DILATOR
K842206 · American Edwards Laboratories · Oct 1984