Cleared Traditional

K063458 - 3M TEGADERM CHG DRESSING

K063458 · 3M Company · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
141d
Days
-
Risk

K063458 is an FDA 510(k) clearance for the 3M TEGADERM CHG DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on April 5, 2007 after a review of 141 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.

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Submission Details

510(k) Number K063458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2006
Decision Date April 05, 2007
Days to Decision 141 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
26d slower than avg
Panel avg: 115d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 213
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K063458.
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
K071552 · Medline Industries, Inc. · Apr 2008
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
K072378 · Arthrex, Inc. · Nov 2007
ALLEVYN AG DRESSING
K063835 · Smith & Nephew, Inc. · Aug 2007
3M TEGADERM SILVER (AG) MESH
K053256 · 3M Company · Dec 2005
MEDLINE IODOFORM PACKING STRIPS
K052720 · Medline Industries, Inc. · Oct 2005
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
K042164 · Medline Industries, Inc. · Jun 2005