Cleared Traditional

K984204 - SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP

K984204 · 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

K984204 is an FDA 510(k) clearance for the SILVERLON DIRECT PRESSURE WOUND CLOSURE 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 - K984204

510(k) Number K984204 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 K984204.
SORBACT WOUND DRESSING
K063059 · Abigo Medical AB · Apr 2007
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 ADHESIVE STRIP
K984205 · Argentum International, LLC · Mar 2007
RETRO-TECH DRESSING
K060832 · Retro-Tech, LLC · Mar 2007
HEALADEX-P
K063517 · Healagenics, Inc. · Feb 2007
K984204 · SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP
Download PDF FDA Summary Argentum Internationa…