Cleared Traditional

Ultrathane Endoureterotomy Stent Set (K160891) - FDA 510(k) Clearance

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

K160891 · Cook Incorporated · Gastroenterology & Urology device
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Jun 2016
Decision
85d
Days
Class 2
Risk

K160891 is an FDA 510(k) clearance for the Ultrathane Endoureterotomy Stent Set. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on June 24, 2016 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4620 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook Incorporated devices

Submission Details

510(k) Number K160891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2016
Decision Date June 24, 2016
Days to Decision 85 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
45d faster than avg
Panel avg: 130d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAD Stent, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4620
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 - FAD Stent, Ureteral

All 51
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K160891.
Kwart Retro-Inject Ureteral Stent
K162109 · Cook Incorporated · Jun 2017
C-Flex Ureteral Stent Set
K162104 · Cook Incorporated · Apr 2017
Universa Firm Ureteral Stents and Stent Sets
K161236 · Cook Incorporated · Jan 2017
Universa Soft Ureteral Stents and Stent Sets
K151051 · Cook Incorporated · Jan 2016
EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
K141344 · Boston Scientific Corp · Oct 2014
BARD INLAYOPTIMA URETERAL STENT WITH SUTURE
K043193 · C.R. Bard, Inc. · Dec 2004