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FDA 510(k)

Howell Biliary Introducer Needle

K-Number: K160890 · 2017-06-14

ApplicantWilson-Cook Medical, Inc.
Decision Date2017-06-14
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Howell Biliary Introducer Needle is a medical device manufactured by Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2017-06-14 under approval number K160890. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Howell Biliary Introducer Needle?

Howell Biliary Introducer Needle is a medical device that received FDA 510(k) clearance on 2017-06-14. It is manufactured by Wilson-Cook Medical, Inc.. The 510(k) number is K160890.

When was Howell Biliary Introducer Needle approved by the FDA?

Howell Biliary Introducer Needle received FDA 510(k) clearance on 2017-06-14, under approval number K160890.

What company makes Howell Biliary Introducer Needle?

Howell Biliary Introducer Needle is manufactured by Wilson-Cook Medical, Inc..

What is the FDA product code for Howell Biliary Introducer Needle?

The FDA product code for Howell Biliary Introducer Needle is FCG.

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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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