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FDA 510(k)

WoundExpress

K-Number: K211200 · 2021-09-03

ApplicantHuntleigh Healthcare , Ltd.
Decision Date2021-09-03
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WoundExpress is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare , Ltd.. It received FDA 510(k) clearance on 2021-09-03 under 510(k) number K211200. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WoundExpress?

WoundExpress is a medical device that received FDA 510(k) clearance on 2021-09-03. The listed applicant is Huntleigh Healthcare , Ltd.. The 510(k) number is K211200.

When did WoundExpress receive FDA 510(k) clearance?

WoundExpress received FDA 510(k) clearance on 2021-09-03, under 510(k) number K211200.

Who is the listed applicant for WoundExpress?

The FDA 510(k) record lists Huntleigh Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WoundExpress?

The FDA product code for WoundExpress is JOW.

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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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