Cleared Traditional

Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (K171810) - FDA 510(k) Clearance

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

K171810 · Cook Incorporated · Gastroenterology & Urology device
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Mar 2018
Decision
261d
Days
Class 2
Risk

K171810 is an FDA 510(k) clearance for the Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on March 7, 2018 after a review of 261 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 K171810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2017
Decision Date March 07, 2018
Days to Decision 261 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
131d slower than avg
Panel avg: 130d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KOD Catheter, Urological

All 58
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K171810.
UroGen Ureteral Catheter
K180354 · Urogen Pharma, Ltd. · Oct 2018
Angled Tip Ureteral Catheter
K181144 · Cook Incorporated · Jun 2018
Imager II Urology Torque Catheter
K180530 · Boston Scientific Corporation · Apr 2018
Renal Access Cobra Catheter, Kumpe Access Catheter
K171600 · Cook Incorporated · Feb 2018
Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter
K171662 · Cook Incorporated · Feb 2018
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP)
K102527 · Boston Scientific Corporation · Nov 2010