Cleared Traditional

K083113 - ACTICOAT FLEX 7 DRESSING

K083113 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
274d
Days
-
Risk

K083113 is an FDA 510(k) clearance for the ACTICOAT FLEX 7 DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Smith & Nephew, Inc. (St Petersburg, US). The FDA issued a Cleared decision on July 22, 2009 after a review of 274 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K083113

510(k) Number K083113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2008
Decision Date July 22, 2009
Days to Decision 274 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
159d slower than avg
Panel avg: 115d · This submission: 274d
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 709
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K083113.
EXSALT SD7 WOUND DRESSING
K083870 · Exciton Technologies, Inc. · Jul 2009
SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND
K091013 · Advanced Medical Solutions Limited · Jul 2009
NEOSALUS LOTION
K091719 · Quinnova Pharmaceuticals · Jul 2009
CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES
K082910 · Aso, LLC · Jun 2009
OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER
K090206 · Oculus Innovative Sciences, Inc. · Jun 2009
OCULUS MICROCYN WOUND GEL
K090725 · Oculus Innovative Sciences, Inc. · May 2009
K083113 · ACTICOAT FLEX 7 DRESSING
Download PDF FDA Summary Smith & Nephew, Inc.