Cleared Traditional

K905375 - ACCENT DG BALLOON URETERAL DILATOR SET

K905375 is the FDA 510(k) clearance for ACCENT DG BALLOON URETERAL DILATOR SET by Cook Urological, 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.

K905375 · Cook Urological, Inc. · Gastroenterology & Urology device
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Apr 1991
Decision
133d
Days
Class 2
Risk

K905375 is an FDA 510(k) clearance for the ACCENT DG BALLOON URETERAL DILATOR SET. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on April 12, 1991 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 Cook Urological, Inc. devices

Submission Details

510(k) Number K905375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1990
Decision Date April 12, 1991
Days to Decision 133 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 42
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K905375.
ACCENT DG BALLOON URTERAL DILATOR SET, 10CM
K915392 · Cook Urological, Inc. · Mar 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
VAN-TEC ONE STEP URETERAL DILATATION CATHETER
K870697 · Van-Tec, Inc. · Mar 1987
URETERAL DILATOR
K852324 · American Edwards Laboratories · Aug 1985