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FDA 510(k)

Howell Biliary Aspiration Needle

K-Number: K153763 · 2017-04-06

ApplicantWilson-Cook Medical, Inc.
Decision Date2017-04-06
Product CodeFCK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Howell Biliary Aspiration Needle 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 2017-04-06 under 510(k) number K153763. The device is classified under product code FCK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Howell Biliary Aspiration Needle?

Howell Biliary Aspiration Needle is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K153763.

When did Howell Biliary Aspiration Needle receive FDA 510(k) clearance?

Howell Biliary Aspiration Needle received FDA 510(k) clearance on 2017-04-06, under 510(k) number K153763.

Who is the listed applicant for Howell Biliary Aspiration Needle?

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 Howell Biliary Aspiration Needle?

The FDA product code for Howell Biliary Aspiration Needle is FCK.

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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.

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