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FDA 510(k)

Soehendra Stent Retriever

K-Number: K161203 · 2016-05-04

ApplicantWilson-Cook Medical, Inc.
Decision Date2016-05-04
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Soehendra Stent Retriever is a medical device manufactured by Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2016-05-04 under approval number K161203. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Soehendra Stent Retriever?

Soehendra Stent Retriever is a medical device that received FDA 510(k) clearance on 2016-05-04. It is manufactured by Wilson-Cook Medical, Inc.. The 510(k) number is K161203.

When was Soehendra Stent Retriever approved by the FDA?

Soehendra Stent Retriever received FDA 510(k) clearance on 2016-05-04, under approval number K161203.

What company makes Soehendra Stent Retriever?

Soehendra Stent Retriever is manufactured by Wilson-Cook Medical, Inc..

What is the FDA product code for Soehendra Stent Retriever?

The FDA product code for Soehendra Stent Retriever is FGE.

Related Clinical Trials

NCT06249776 Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial COMPLETED

Other Devices by Wilson-Cook Medical, Inc.

K160170Lehman Manometry Catheter K171573Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter K170292Tri-Ex Extraction Balloon With Multiple Sizing K171596ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle K171223Quantum TTC Biliary Balloon Dilator

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Related Devices (Code: FGE)

K163018Zilver 635 Biliary StentCook Ireland, Ltd. K162404Express SD Biliary Monorail Premounted Stent SystemBoston Scientific Corporation K150487X-Suit NIR Biliary Metallic StentMedinol, Ltd. K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc. K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation K171809Epic Biliary Endoscopic Stent SystemBoston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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