Cleared Traditional

K162109 - Kwart Retro-Inject Ureteral Stent

K162109 is an FDA 510(k) clearance for Kwart Retro-Inject Ureteral Stent, manufactured by Cook Incorporated. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K162109 · Cook Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
313d
Days
Class 2
Risk

K162109 is an FDA 510(k) clearance for the Kwart Retro-Inject Ureteral Stent. 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 7, 2017 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K162109

510(k) Number K162109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2016
Decision Date June 07, 2017
Days to Decision 313 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
182d slower than avg
Panel avg: 131d · This submission: 313d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAD Device Classification - Class 2, Special Controls

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 112
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K162109.
pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
K172289 · Q Urological Corporation · Oct 2017
Salle Intraoperative Pyeloplasty Stent Set
K170010 · Cook Incorporated · Aug 2017
Tria Firm Ureteral Stent
K163399 · Boston Scientific Corporation · Jun 2017
C-Flex Ureteral Stent Set
K162104 · Cook Incorporated · Apr 2017
Universa Firm Ureteral Stents and Stent Sets
K161236 · Cook Incorporated · Jan 2017
pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
K163068 · Q Urological Corporation · Dec 2016