Cleared Traditional

VIADERM (K882590) - FDA 510(k) Clearance

K882590 · Applied Biomedical Sciences · General & Plastic Surgery device
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Oct 1988
Decision
106d
Days
-
Risk

K882590 is an FDA 510(k) clearance for the VIADERM. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Applied Biomedical Sciences (Long Beach, US). The FDA issued a Cleared decision on October 7, 1988 after a review of 106 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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Submission Details

510(k) Number K882590 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 23, 1988
Decision Date October 07, 1988
Days to Decision 106 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
9d faster than avg
Panel avg: 115d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -