Cleared Traditional

K153648 - Microcyn Plus Skin and Wound Hydrogel

K153648 · Oculus Innovative Sciences · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
120d
Days
-
Risk

K153648 is an FDA 510(k) clearance for the Microcyn Plus Skin and Wound Hydrogel. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Oculus Innovative Sciences (Petaluma, US). The FDA issued a Cleared decision on April 19, 2016 after a review of 120 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.

FDA 510(k) Submission Details - K153648

510(k) Number K153648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2015
Decision Date April 19, 2016
Days to Decision 120 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
5d slower than avg
Panel avg: 115d · This submission: 120d
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 638
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