Cleared Traditional

K023609 - SILVERLON ADHESIVE STRIP

K023609 · Argentum International, LLC · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jan 2003
Decision
81d
Days
-
Risk

K023609 is an FDA 510(k) clearance for the SILVERLON ADHESIVE STRIP. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Argentum International, LLC (Lakemont, US). The FDA issued a Cleared decision on January 17, 2003 after a review of 81 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.

View all Argentum International, LLC devices

FDA 510(k) Submission Details - K023609

510(k) Number K023609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2002
Decision Date January 17, 2003
Days to Decision 81 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 115d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 294
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DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
K012816 · Dynarex Corp. · Oct 2002
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K013814 · Convatec, A Division of E.R. Squibb & Sons · Jun 2002
SILVERLON WOUND PACKING STRIPS
K984210 · Argentum International, LLC · Sep 1999