Cleared Traditional

K073213 - THERABOND ANTIMICROBIAL BARRIER SYSTEMS

K073213 · Choice Therapeutics · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
196d
Days
-
Risk

K073213 is an FDA 510(k) clearance for the THERABOND ANTIMICROBIAL BARRIER SYSTEMS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Choice Therapeutics (Washington, D.C., US). The FDA issued a Cleared decision on May 28, 2008 after a review of 196 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.

View all Choice Therapeutics devices

FDA 510(k) Submission Details - K073213

510(k) Number K073213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2007
Decision Date May 28, 2008
Days to Decision 196 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 115d · This submission: 196d
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 239
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K073213.
PROWICK
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K090141 · B.Braun Medical, Inc. · Mar 2009
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K072876 · B.Braun Medical, Inc. · Jun 2008
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
K071552 · Medline Industries, Inc. · Apr 2008
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
K072378 · Arthrex, Inc. · Nov 2007
ALLEVYN AG DRESSING
K063835 · Smith & Nephew, Inc. · Aug 2007