Cleared Special

K103141 - LOW ADHERENT AFM AG DRESSINGS

K103141 · Milliken Healthcare Products, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
88d
Days
-
Risk

K103141 is an FDA 510(k) clearance for the LOW ADHERENT AFM AG DRESSINGS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Milliken Healthcare Products, LLC (San Diego, US). The FDA issued a Cleared decision on January 21, 2011 after a review of 88 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.

View all Milliken Healthcare Products, LLC devices

FDA 510(k) Submission Details - K103141

510(k) Number K103141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2010
Decision Date January 21, 2011
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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
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