Cleared Special

K080620 - MODIFICATION TO 3M TEGADERM CHG DRESSING

K080620 · 3M Company-3M Health Care · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
76d
Days
-
Risk

K080620 is an FDA 510(k) clearance for the MODIFICATION TO 3M TEGADERM CHG DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by 3M Company-3M Health Care (St. Paul, US). The FDA issued a Cleared decision on May 19, 2008 after a review of 76 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 - K080620

510(k) Number K080620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2008
Decision Date May 19, 2008
Days to Decision 76 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 115d · This submission: 76d
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 247
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K080620.
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PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
K071552 · Medline Industries, Inc. · Apr 2008
DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
K080315 · Derma Sciences, Inc. · Apr 2008
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
K072378 · Arthrex, Inc. · Nov 2007