Cleared Traditional

K984205 - SILVERLON ADHESIVE STRIP

K984205 · Argentum International, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
3037d
Days
-
Risk

K984205 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 March 19, 2007 after a review of 3037 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K984205

510(k) Number K984205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1998
Decision Date March 19, 2007
Days to Decision 3037 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2922d slower than avg
Panel avg: 115d · This submission: 3037d
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 664
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K984205.
AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING
K063271 · Convatec, A Division of E.R. Squibb & Sons, LLC · Apr 2007
3M TEGADERM CHG DRESSING
K063458 · 3M Company · Apr 2007
SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP
K984204 · Argentum International, LLC · Mar 2007
RETRO-TECH DRESSING
K060832 · Retro-Tech, LLC · Mar 2007
HEALADEX-P
K063517 · Healagenics, Inc. · Feb 2007
EXSEPT WC WOUND CLEANSER
K061467 · Alcavis International, Inc. · Feb 2007
K984205 · SILVERLON ADHESIVE STRIP
Download PDF FDA Summary Argentum Internationa…