Cleared Traditional

K984210 - SILVERLON WOUND PACKING STRIPS

K984210 · Argentum International, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
304d
Days
-
Risk

K984210 is an FDA 510(k) clearance for the SILVERLON WOUND PACKING STRIPS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Argentum International, LLC (Lakemont, US). The FDA issued a Cleared decision on September 24, 1999 after a review of 304 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Argentum International, LLC devices

FDA 510(k) Submission Details - K984210

510(k) Number K984210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1998
Decision Date September 24, 1999
Days to Decision 304 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
189d slower than avg
Panel avg: 115d · This submission: 304d
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 293
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K984210.
CONTREET FOAM ADHESIVE/NON-ADHESIVE
K022416 · Coloplast Corp. · Feb 2003
DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
K012816 · Dynarex Corp. · Oct 2002
ABSORBENT ANTIMICROBIAL WOUND DRESSING
K013814 · Convatec, A Division of E.R. Squibb & Sons · Jun 2002
DUMEX IODOFORM PACKING STRIP
K990332 · Dumex Medical Surgical Products, Ltd. · Apr 1999
SILON DUAL-DRESS
K990042 · Bio Med Sciences, Inc. · Mar 1999
MODIFICATION OF CUTINOVA THIN DRESSING
K984593 · Beiersdorf-Jobt, Inc. · Mar 1999