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FDA 510(k)

Howell D.A.S.H Extraction Balloon with Multiple Sizing

K-Number: K173659 · 2018-07-06

ApplicantWilson-Cook Medical, Inc.
Decision Date2018-07-06
Product CodeGCA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Howell D.A.S.H Extraction Balloon with Multiple Sizing is a medical device manufactured by Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2018-07-06 under approval number K173659. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Howell D.A.S.H Extraction Balloon with Multiple Sizing?

Howell D.A.S.H Extraction Balloon with Multiple Sizing is a medical device that received FDA 510(k) clearance on 2018-07-06. It is manufactured by Wilson-Cook Medical, Inc.. The 510(k) number is K173659.

When was Howell D.A.S.H Extraction Balloon with Multiple Sizing approved by the FDA?

Howell D.A.S.H Extraction Balloon with Multiple Sizing received FDA 510(k) clearance on 2018-07-06, under approval number K173659.

What company makes Howell D.A.S.H Extraction Balloon with Multiple Sizing?

Howell D.A.S.H Extraction Balloon with Multiple Sizing is manufactured by Wilson-Cook Medical, Inc..

What is the FDA product code for Howell D.A.S.H Extraction Balloon with Multiple Sizing?

The FDA product code for Howell D.A.S.H Extraction Balloon with Multiple Sizing is GCA.

Related Clinical Trials

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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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