FDA 510(k)

WoundExpress

K-Number: K211200 · 2021-09-03

Decision Date2021-09-03

Product CodeJOW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

WoundExpress is a medical device manufactured by Huntleigh Healthcare , Ltd.. It received FDA 510(k) clearance on 2021-09-03 under approval 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. It is manufactured by Huntleigh Healthcare , Ltd.. The 510(k) number is K211200.

When was WoundExpress approved by the FDA?

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

What company makes WoundExpress?

WoundExpress is manufactured by Huntleigh Healthcare , Ltd..

What is the FDA product code for WoundExpress?

The FDA product code for WoundExpress is JOW.

Other Devices by Huntleigh Healthcare , Ltd.

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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.