Cleared Traditional

Cook 810 Set, Desilets-Hoffman Introducer Set (K180028) - FDA 510(k) Clearance

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

K180028 · Cook Incorporated · Gastroenterology & Urology device
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May 2018
Decision
119d
Days
Class 2
Risk

K180028 is an FDA 510(k) clearance for the Cook 810 Set, Desilets-Hoffman Introducer Set. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 2, 2018 after a review of 119 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 Incorporated devices

Submission Details

510(k) Number K180028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2018
Decision Date May 02, 2018
Days to Decision 119 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 130d · This submission: 119d
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 25
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K180028.
EQUINOX Balloon Dilatation Catheter
K190612 · Dornier Medtech America, Inc. · Dec 2019
Ureteral Dilator Sets, Ureteral Dilators
K173654 · Cook Incorporated · Jul 2018
Safety Wire Guide Introducer
K180756 · Cook Incorporated · May 2018
Balloon Catheter and Balloon Ureteral Dilator Set
K172588 · Cook Incorporated · Apr 2018
UROMAX ULTRA BALLOON DILATATION CATHETER
K130804 · Boston Scientific Corporation · May 2013
U-BALLOON DILATION CATHETER
K050875 · C.R. Bard, Inc. · May 2005