Cleared Special

Antimicrobial Silicone PHMB Foam Wound Dressing

K223310 · Advanced Medical Solutions Limited · General & Plastic Surgery
Apr 2023
Decision
159d
Days
—
Risk

About This 510(k) Submission

K223310 is an FDA 510(k) clearance for the Antimicrobial Silicone PHMB Foam Wound Dressing, a Dressing, Wound, Drug, submitted by Advanced Medical Solutions Limited (Winsford, GB). The FDA issued a Cleared decision on April 5, 2023, 159 days after receiving the submission on October 28, 2022. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K223310 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2022
Decision Date April 05, 2023
Days to Decision 159 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class —

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