Cleared Special

K161203 - Soehendra Stent Retriever

K161203 is an FDA 510(k) clearance for Soehendra Stent Retriever, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 6-day FDA review.

K161203 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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May 2016
Decision
6d
Days
Class 2
Risk

K161203 is an FDA 510(k) clearance for the Soehendra Stent Retriever. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on May 4, 2016 after a review of 6 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Wilson-Cook Medical, Inc. devices

FDA 510(k) Submission Details - K161203

510(k) Number K161203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2016
Decision Date May 04, 2016
Days to Decision 6 days
Submission Type Special
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
124d faster than avg
Panel avg: 130d · This submission: 6d
Pathway characteristics
Modification to existing cleared device.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 360
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K161203.
Reliant Multistage Dilatation Balloon Catheter
K162226 · Micro-Tech (Nanjing) Co., Ltd. · Jan 2017
Zilver 635 Biliary Stent
K163018 · Cook Ireland, Ltd. · Dec 2016
Express SD Biliary Monorail Premounted Stent System
K162404 · Boston Scientific Corporation · Oct 2016
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
K152853 · Boston Scientific Corp · Nov 2015
Elation Wireguided Balloon Dilation Catheter
K151925 · Merit Medical Systems, Inc. · Nov 2015
Express SD Biliary Monorail Premounted Stent System
K152607 · Boston Scientific · Oct 2015