Cleared Special

K083007 - PROWICK

K083007 · Arthrex, Inc. · General & Plastic Surgery device
Download Printable Device Report (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.

View all Arthrex, Inc. devices

Submission Details

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.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 221
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