Cleared Traditional

K110457 - 3M TEGADERM MATRIX DRESSING

K110457 · 3M Company · General & Plastic Surgery device
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Dec 2011
Decision
293d
Days
-
Risk

K110457 is an FDA 510(k) clearance for the 3M TEGADERM MATRIX DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on December 7, 2011 after a review of 293 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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FDA 510(k) Submission Details - K110457

510(k) Number K110457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2011
Decision Date December 07, 2011
Days to Decision 293 days
Submission Type Traditional
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
178d slower than avg
Panel avg: 115d · This submission: 293d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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