Cleared Traditional

K004028 - ARGLAES-AB ANTIMICROBIAL BARRIER POWDER...

K004028 · Maersk Medical, Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2001
Decision
90d
Days
-
Risk

K004028 is an FDA 510(k) clearance for the ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Maersk Medical, Ltd. (Mundelein, US). The FDA issued a Cleared decision on March 27, 2001 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Maersk Medical, Ltd. devices

FDA 510(k) Submission Details - K004028

510(k) Number K004028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2000
Decision Date March 27, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
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 242
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K983173 · Coloplast Corp. · Dec 1998