Cleared Traditional

K172851 - Microcyn Plus Antimicrobial Wound Care Solution

K172851 · Sonoma Pharmaceuticals, Inc. · General & Plastic Surgery device
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Nov 2017
Decision
56d
Days
-
Risk

K172851 is an FDA 510(k) clearance for the Microcyn Plus Antimicrobial Wound Care Solution. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Sonoma Pharmaceuticals, Inc. (Petaluma, US). The FDA issued a Cleared decision on November 15, 2017 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sonoma Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K172851

510(k) Number K172851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2017
Decision Date November 15, 2017
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
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 601
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K172851.
3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing
K170754 · 3M Company, 3M Healthcare · Nov 2017
Microcyn Antimicrobial Skin and Wound Cleanser
K172622 · Sonoma Pharmaceuticals · Nov 2017
Endoform Silver Dermal Template
K172318 · Aroa Biosurgery · Nov 2017
Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle
K172486 · Anexa Biomedical, Inc. · Sep 2017
Hexagen Derm
K171191 · Global Health Solutions, LLC · Aug 2017
NEOCERA Advanced Barrier Cream
K170911 · Exeltis USA Dermatology, LLC · Aug 2017