Cleared Special

K020077 - MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K020077 · Augustine Medical, Inc. · General & Plastic Surgery device
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Jan 2002
Decision
22d
Days
Class 1
Risk

K020077 is an FDA 510(k) clearance for the MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX. Classified as Dressing, Wound And Burn, Occlusive, Heated (product code MSA), Class I - General Controls.

Submitted by Augustine Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on January 31, 2002 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - the FDA general and plastic surgery device framework. 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.

View all Augustine Medical, Inc. devices

Submission Details

510(k) Number K020077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2002
Decision Date January 31, 2002
Days to Decision 22 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
92d faster than avg
Panel avg: 114d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MSA Dressing, Wound And Burn, Occlusive, Heated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.