Cleared Traditional

K122817 - SILVERLON ISLAND WOUND DRESSING

K122817 · Argentum Medical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
594d
Days
-
Risk

K122817 is an FDA 510(k) clearance for the SILVERLON ISLAND WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Argentum Medical, LLC (Glen Burnie, US). The FDA issued a Cleared decision on May 1, 2014 after a review of 594 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.

View all Argentum Medical, LLC devices

FDA 510(k) Submission Details - K122817

510(k) Number K122817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2012
Decision Date May 01, 2014
Days to Decision 594 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
479d slower than avg
Panel avg: 115d · This submission: 594d
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 600
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