Cleared Special

Antimicrobial Silicone PHMB Foam Wound Dressing (K223310) - FDA 510(k) Clearance

K223310 · Advanced Medical Solutions Limited · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
159d
Days
-
Risk

K223310 is an FDA 510(k) clearance for the Antimicrobial Silicone PHMB Foam Wound Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Advanced Medical Solutions Limited (Winsford, GB). The FDA issued a Cleared decision on April 5, 2023 after a review of 159 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Advanced Medical Solutions Limited devices

Submission Details

510(k) Number K223310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 115d · This submission: 159d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 168
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K223310.
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 · Aug 2023
Antibacterial Bandage
K221311 · Winner Medical Co., Ltd. · Jun 2023
coactiv+™ Antimicrobial Wound Gel
K223259 · Kane Biotech, Inc. · May 2023
BIASURGE Advanced Surgical Solution
K223377 · Rochal Technologies, LLC · Mar 2023
Sterile Silver Alginate Wound Dressing
K220673 · Qingdao Bright Moon Biomedical Materials Co., Ltd. · Mar 2023
PHMB Wound Dressing
K221532 · Winner Medical Co., Ltd. · Jan 2023