Cleared Traditional

K161034 - Microcyn Plus Wound Care Solution

K161034 · Oculus Innovative Sciences · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
128d
Days
-
Risk

K161034 is an FDA 510(k) clearance for the Microcyn Plus Wound Care Solution. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Oculus Innovative Sciences (Petaluma, US). The FDA issued a Cleared decision on August 19, 2016 after a review of 128 days - within the typical 510(k) review window.

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 Oculus Innovative Sciences devices

FDA 510(k) Submission Details - K161034

510(k) Number K161034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2016
Decision Date August 19, 2016
Days to Decision 128 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
13d slower than avg
Panel avg: 115d · This submission: 128d
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 261
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K161034.
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
ACTICOAT Surgical Dressing
K153723 · Smith & Nephew Medical Limited · Sep 2016
Exufiber Ag+
K160379 · Molnlycke Health Care Us, LLC · Aug 2016
LUOFUCON Silicone Ag foam dressing
K160022 · Huizhou Foryou Medical Devices Co., Ltd. · Aug 2016
DURAFIBER Ag
K161289 · Smith & Nephew Medical Limited · Aug 2016
Medihoney Wound Gel
K150985 · Derma Sciences, Inc. · Nov 2015