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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FDA 510(k) Submission Details - K063458

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.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 471
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K063458.
ALLEVYN AG DRESSING
K063835 · Smith & Nephew, Inc. · Aug 2007
L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE
K053613 · Theo Manufacturing BV · Jul 2007
HONEY ALGINATE DRESSING
K053095 · Derma Sciences Canada, Inc. · Jul 2007
SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP
K984204 · Argentum International, LLC · Mar 2007
SILVERLON ADHESIVE STRIP
K984205 · Argentum International, LLC · Mar 2007
RETRO-TECH DRESSING
K060832 · Retro-Tech, LLC · Mar 2007