Cleared Traditional

BIOSOFT DUO DOUBLE LOOP URETERAL STENTS (K170422) - FDA 510(k) Clearance

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

K170422 · Coloplast Corp. · Gastroenterology & Urology device
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Nov 2017
Decision
262d
Days
Class 2
Risk

K170422 is an FDA 510(k) clearance for the BIOSOFT DUO DOUBLE LOOP URETERAL STENTS. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on November 2, 2017 after a review of 262 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 Coloplast Corp. devices

Submission Details

510(k) Number K170422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2017
Decision Date November 02, 2017
Days to Decision 262 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 130d · This submission: 262d
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 52
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K170422.
Black Silicone Filiform Double Pigtail Stent Set
K172017 · Cook Incorporated · Mar 2018
RocaJJ Soft Stents
K173734 · Promepla Sam · Mar 2018
VORTEK URETERAL DOUBLE LOOP STENT
K180057 · Coloplast Corp. · Mar 2018
Salle Intraoperative Pyeloplasty Stent Set
K170010 · Cook Incorporated · Aug 2017
Tria Firm Ureteral Stent
K163399 · Boston Scientific Corporation · Jun 2017
Kwart Retro-Inject Ureteral Stent
K162109 · Cook Incorporated · Jun 2017