Cleared Traditional

K963293 - AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K963293 · Augustine Medical, Inc. · General & Plastic Surgery device
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Mar 1997
Decision
219d
Days
Class 1
Risk

K963293 is an FDA 510(k) clearance for the 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 March 28, 1997 after a review of 219 days - an extended review 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. 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.

View all Augustine Medical, Inc. devices

Submission Details

510(k) Number K963293 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 21, 1996
Decision Date March 28, 1997
Days to Decision 219 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 114d · This submission: 219d
Pathway characteristics
Predicate-based equivalence.

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.