Cleared Traditional

FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING (K003134) - FDA 510(k) Clearance

K003134 · Adri/Technam · General & Plastic Surgery device
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Dec 2000
Decision
77d
Days
-
Risk

K003134 is an FDA 510(k) clearance for the FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Adri/Technam (Park Forest, US). The FDA issued a Cleared decision on December 22, 2000 after a review of 77 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 K003134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2000
Decision Date December 22, 2000
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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