Cleared Special

K083007 - PROWICK

K083007 · Arthrex, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
182d
Days
-
Risk

K083007 is an FDA 510(k) clearance for the PROWICK. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on April 8, 2009 after a review of 182 days - an extended review 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. 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.

FDA 510(k) Submission Details - K083007

510(k) Number K083007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2008
Decision Date April 08, 2009
Days to Decision 182 days
Submission Type Special
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
67d slower than avg
Panel avg: 115d · This submission: 182d
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 709
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K083007.
OCULUS MICROCYN WOUND GEL
K090725 · Oculus Innovative Sciences, Inc. · May 2009
SOCKIT! AND MCMERLIN DERMAL WOUND GEL
K090092 · Mcmerlin Dental Products LP · May 2009
SILVER WOUND PAD
K083659 · Milliken & Co. · Apr 2009
ASAP WOUND DRESSING GEL
K082333 · American Biotech Labs · Apr 2009
NEOSALUS CREAM
K090585 · Quinnova Pharmaceuticals · Apr 2009
PRONTOSAN ANTIMICROBIAL WOUND GEL
K090141 · B.Braun Medical, Inc. · Mar 2009
K083007 · PROWICK
Download PDF FDA Summary Arthrex, Inc.