Cleared Traditional

K113583 - CURAD ANTIBACTERIAL BANDAGE

K113583 · Medline Industries, Inc. · General & Plastic Surgery device
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Apr 2012
Decision
129d
Days
-
Risk

K113583 is an FDA 510(k) clearance for the CURAD ANTIBACTERIAL BANDAGE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on April 12, 2012 after a review of 129 days - within the typical 510(k) review window.

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.

View all Medline Industries, Inc. devices

Submission Details

510(k) Number K113583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2011
Decision Date April 12, 2012
Days to Decision 129 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 115d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 205
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