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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 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 2018-07-06 under 510(k) 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. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K173659.

When did Howell D.A.S.H Extraction Balloon with Multiple Sizing receive FDA 510(k) clearance?

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

Who is the listed applicant for Howell D.A.S.H Extraction Balloon with Multiple Sizing?

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 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.

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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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