Cleared Traditional

K100948 - HYPO CLENZ WOUND WASH MODEL 100 PPM

K100948 · Nevoa Life Sciences, LLC · General & Plastic Surgery device
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Feb 2011
Decision
302d
Days
-
Risk

K100948 is an FDA 510(k) clearance for the HYPO CLENZ WOUND WASH MODEL 100 PPM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Nevoa Life Sciences, LLC (Carmichael, US). The FDA issued a Cleared decision on February 2, 2011 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K100948

510(k) Number K100948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2010
Decision Date February 02, 2011
Days to Decision 302 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 115d · This submission: 302d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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SORBACT
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K103141 · Milliken Healthcare Products, LLC · Jan 2011
K100948 · HYPO CLENZ WOUND WASH MODEL 100 PPM
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