Cleared Traditional

K050030 - ACTICOAT MOISTURE CONTROL DRESSING

K050030 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
104d
Days
-
Risk

K050030 is an FDA 510(k) clearance for the ACTICOAT MOISTURE CONTROL DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Smith & Nephew, Inc. (Largo, US). The FDA issued a Cleared decision on April 21, 2005 after a review of 104 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 Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K050030

510(k) Number K050030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2005
Decision Date April 21, 2005
Days to Decision 104 days
Submission Type Traditional
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
11d faster than avg
Panel avg: 115d · This submission: 104d
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 471
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