Cleared Traditional

K023609 - SILVERLON ADHESIVE STRIP

K023609 · 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
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.

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
Combination Product No
PCCP Authorized No
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 664
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K023609.
ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING
K022483 · Johnson & Johnson Medical, Ltd. · Feb 2003
SILVERLON CONTACT WOUND DRESSING
K023612 · Argentum International, LLC · Jan 2003
HYDROFERA BACTERIOSTATIC WOUND DRESSING
K023138 · Hydrofera, LLC · Jan 2003
CALGITROL AG SILVER ALGINATE WOUND DRESSING
K011618 · Adri · Nov 2002
DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
K012816 · Dynarex Corp. · Oct 2002
CARRAKLENZ AND ULTRAKLENZ
K022670 · Carrington Laboratories, Inc. · Oct 2002
K023609 · SILVERLON ADHESIVE STRIP
Download PDF FDA Summary Argentum Internationa…