Cleared Special

K053256 - 3M TEGADERM SILVER (AG) MESH

K053256 · 3M Company · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2005
Decision
24d
Days
-
Risk

K053256 is an FDA 510(k) clearance for the 3M TEGADERM SILVER (AG) MESH. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on December 16, 2005 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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FDA 510(k) Submission Details - K053256

510(k) Number K053256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2005
Decision Date December 16, 2005
Days to Decision 24 days
Submission Type Special
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
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 561
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