Cleared Special

K143001 - SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING

K143001 · Argentum Medical · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
21d
Days
-
Risk

K143001 is an FDA 510(k) clearance for the SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Argentum Medical (Geneva, US). The FDA issued a Cleared decision on November 7, 2014 after a review of 21 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 - K143001

510(k) Number K143001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2014
Decision Date November 07, 2014
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
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 K143001.
Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)
K143151 · Bsn Medical GmbH · Jan 2015
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K133729 · Manuka Health New Zealand , Ltd. · Jan 2015
CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4
K140389 · Entrotech Life Sciences, Inc. · Nov 2014
NAWALUTION SKIN AND WOUND CLEANSER
K141660 · Nawa Heilmittel GmbH · Oct 2014
Ultra Silver Dressings
K141603 · Milliken Healthcare Products, LLC · Oct 2014
SILVERLON ISLAND WOUND DRESSING
K141573 · Argentum Medical · Aug 2014