Cleared Special

K141603 - Ultra Silver Dressings

K141603 · Milliken Healthcare Products, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
128d
Days
-
Risk

K141603 is an FDA 510(k) clearance for the Ultra Silver Dressings. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Milliken Healthcare Products, LLC (Marlborough, US). The FDA issued a Cleared decision on October 22, 2014 after a review of 128 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Milliken Healthcare Products, LLC devices

FDA 510(k) Submission Details - K141603

510(k) Number K141603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2014
Decision Date October 22, 2014
Days to Decision 128 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 115d · This submission: 128d
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 242
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K141603.
MEDIHONEY WOUND DRESSINGS
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K140954 · Huizhou Foryou Medical Devices Co., Ltd. · Mar 2015
PRONTOSAN WOUND GEL X
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3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
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LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
K120181 · Huizhou Foryou Medical Devices Co., Ltd. · Feb 2013