Cleared Traditional

VIADERM (K914024) - FDA 510(k) Clearance

K914024 · Abs Life Sciences · General & Plastic Surgery device
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Dec 1991
Decision
85d
Days
-
Risk

K914024 is an FDA 510(k) clearance for the VIADERM. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Abs Life Sciences (West Chester, US). The FDA issued a Cleared decision on December 4, 1991 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K914024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1991
Decision Date December 04, 1991
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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