Cleared Special

K141573 - SILVERLON ISLAND WOUND DRESSING

K141573 · Argentum Medical · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
77d
Days
-
Risk

K141573 is an FDA 510(k) clearance for the SILVERLON ISLAND WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Argentum Medical (Geneva, US). The FDA issued a Cleared decision on August 28, 2014 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K141573

510(k) Number K141573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2014
Decision Date August 28, 2014
Days to Decision 77 days
Submission Type Special
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
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 638
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K141573.
SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING
K143001 · Argentum Medical · Nov 2014
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IONSIL GEL
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HYDROCLEANSE WOUND CARE SOLUTION
K141012 · Oculus Innovative Sciences · Aug 2014
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
K132891 · The Hymed Group Corp. · Jun 2014