Cleared Traditional

K071056 - NEUTROPHASE WOUND CLEANSER

K071056 · Novabay Pharmaceuticals · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
165d
Days
-
Risk

K071056 is an FDA 510(k) clearance for the NEUTROPHASE WOUND CLEANSER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Novabay Pharmaceuticals (Emeryville, US). The FDA issued a Cleared decision on September 28, 2007 after a review of 165 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 - K071056

510(k) Number K071056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2007
Decision Date September 28, 2007
Days to Decision 165 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 115d · This submission: 165d
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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