Cleared Traditional

Sof-Flex Ureteral Stent Set (K180053) - FDA 510(k) Clearance

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

K180053 · Cook Incorporated · Gastroenterology & Urology device
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Sep 2018
Decision
248d
Days
Class 2
Risk

K180053 is an FDA 510(k) clearance for the Sof-Flex Ureteral 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 September 13, 2018 after a review of 248 days - an extended review 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: 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 K180053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2018
Decision Date September 13, 2018
Days to Decision 248 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
118d slower than avg
Panel avg: 130d · This submission: 248d
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 K180053.
ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
K180469 · Coloplast Corp. · Nov 2018
Seidmon Antegrade AQ Stent Set
K180216 · Cook Incorporated · Sep 2018
Malecot Nephrostomy Catheter/Stent Set
K180029 · Cook Incorporated · Sep 2018
Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set
K171603 · Cook Incorporated · Apr 2018
Black Silicone Filiform Double Pigtail Stent Set
K172017 · Cook Incorporated · Mar 2018
RocaJJ Soft Stents
K173734 · Promepla Sam · Mar 2018