Cleared Traditional

K233151 - PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) (FDA 510(k) Clearance)

K233151 · Medline Industries, LP · General & Plastic Surgery device

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Mar 2024

Decision

181d

Days

Risk

K233151 is an FDA 510(k) clearance for the PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dre.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on March 26, 2024 after a review of 181 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number	K233151 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 27, 2023
Decision Date	March 26, 2024
Days to Decision	181 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
PCCP Authorized	No