Cleared Traditional

ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing

K223526 · Smith & Nephew Medical Limited · General & Plastic Surgery
Aug 2023
Decision
268d
Days
Risk

About This 510(k) Submission

K223526 is an FDA 510(k) clearance for the ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, a Dressing, Wound, Drug, submitted by Smith & Nephew Medical Limited (Hull, GB). The FDA issued a Cleared decision on August 18, 2023, 268 days after receiving the submission on November 23, 2022. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K223526 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2022
Decision Date August 18, 2023
Days to Decision 268 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class

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