Cleared Traditional

WoundExpress

K211200 · Huntleigh Healthcare , Ltd. · Cardiovascular
Sep 2021
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K211200 is an FDA 510(k) clearance for the WoundExpress, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Huntleigh Healthcare , Ltd. (Cardiff, GB). The FDA issued a Cleared decision on September 3, 2021, 134 days after receiving the submission on April 22, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K211200 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2021
Decision Date September 03, 2021
Days to Decision 134 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code JOW — Sleeve, Limb, Compressible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5800

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