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
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 239
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K113820.
PRONTOSAN WOUND GEL X
K130857 · B.Braun Medical, Inc. · Oct 2013
3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
K123679 · 3M Company · Feb 2013
LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
K120181 · Huizhou Foryou Medical Devices Co., Ltd. · Feb 2013
CURAD ANTIBACTERIAL BANDAGE
K113583 · Medline Industries, Inc. · Apr 2012
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES
K120828 · Coloplast A/S · Apr 2012
3M TEGADERM MATRIX DRESSING
K110457 · 3M Company · Dec 2011