Cleared Traditional

K051542 - TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING

K051542 · Triosyn Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
280d
Days
-
Risk

K051542 is an FDA 510(k) clearance for the TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Triosyn Corp. (Williston, US). The FDA issued a Cleared decision on March 17, 2006 after a review of 280 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 Triosyn Corp. devices

FDA 510(k) Submission Details - K051542

510(k) Number K051542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2005
Decision Date March 17, 2006
Days to Decision 280 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
165d slower than avg
Panel avg: 115d · This submission: 280d
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 607
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