Cleared Traditional

K113820 - NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER

K113820 · Novabay Pharmaceuticals · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
225d
Days
-
Risk

K113820 is an FDA 510(k) clearance for the NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Novabay Pharmaceuticals (Los Altos, US). The FDA issued a Cleared decision on August 8, 2012 after a review of 225 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 Novabay Pharmaceuticals devices

FDA 510(k) Submission Details - K113820

510(k) Number K113820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2011
Decision Date August 08, 2012
Days to Decision 225 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
110d slower than avg
Panel avg: 115d · This submission: 225d
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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