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FDA 510(k)

Soehendra Stent Retriever

K-Number: K161203 · 2016-05-04

Decision Date2016-05-04
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Soehendra Stent Retriever is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2016-05-04 under 510(k) 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. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K161203.

When did Soehendra Stent Retriever receive FDA 510(k) clearance?

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

Who is the listed applicant for Soehendra Stent Retriever?

The FDA 510(k) record lists Wilson-Cook Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Soehendra Stent Retriever?

The FDA product code for Soehendra Stent Retriever is FGE.

Other records listing Wilson-Cook Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 34 devices →

Related Devices (Code: FGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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