Cleared Traditional

K072378 - PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626

K072378 · Arthrex, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
77d
Days
-
Risk

K072378 is an FDA 510(k) clearance for the PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on November 9, 2007 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K072378

510(k) Number K072378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2007
Decision Date November 09, 2007
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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K072378 · PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
Download PDF FDA Summary Arthrex, Inc.