Cleared Traditional

PURACYN PLUS SKIN AND WOUND (K133542) - FDA 510(k) Clearance

K133542 · Innovacyn, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
161d
Days
-
Risk

K133542 is an FDA 510(k) clearance for the PURACYN PLUS SKIN AND WOUND. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Innovacyn, Inc. (Rialto, US). The FDA issued a Cleared decision on April 28, 2014 after a review of 161 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 Innovacyn, Inc. devices

Submission Details

510(k) Number K133542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2013
Decision Date April 28, 2014
Days to Decision 161 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
46d slower than avg
Panel avg: 115d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 169
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K133542.
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PRONTOSAN WOUND GEL X
K130857 · B.Braun Medical, Inc. · Oct 2013
3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
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CURAD ANTIBACTERIAL BANDAGE
K113583 · Medline Industries, Inc. · Apr 2012