Cleared Traditional

Alevicyn SG Antimicrobial Gel (K171935) - FDA 510(k) Clearance

K171935 · Sonoma Pharmaceuticals, Inc. · General & Plastic Surgery device
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Dec 2017
Decision
156d
Days
-
Risk

K171935 is an FDA 510(k) clearance for the Alevicyn SG Antimicrobial Gel. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Sonoma Pharmaceuticals, Inc. (Petaluma, US). The FDA issued a Cleared decision on December 1, 2017 after a review of 156 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 Sonoma Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K171935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2017
Decision Date December 01, 2017
Days to Decision 156 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
41d slower than avg
Panel avg: 115d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 169
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K171935.
Algidex Ag Silver Alginate Wound Dressing
K173072 · Deroyal Industries, Inc. · Apr 2018
Microcyn Antimicrobial Hydrogel
K173896 · Sonoma Pharmaceuticals, Inc. · Apr 2018
Catasyn Advanced Technology Wound Hydrogel
K172338 · Synedgen, Inc. · Feb 2018
Prontosan Wound Gel
K163430 · B.Braun Medical, Inc. · May 2017
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
K161623 · B.Braun Medical, Inc. · Nov 2016
PRONTOSAN WOUND GEL X
K130857 · B.Braun Medical, Inc. · Oct 2013