Cleared Traditional

K041161 - MICROCYN WOUND CARE DRESSING

K041161 · Oculus Innovative Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
365d
Days
-
Risk

K041161 is an FDA 510(k) clearance for the MICROCYN WOUND CARE DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Oculus Innovative Sciences, Inc. (Petaluma, US). The FDA issued a Cleared decision on May 3, 2005 after a review of 365 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.

View all Oculus Innovative Sciences, Inc. devices

FDA 510(k) Submission Details - K041161

510(k) Number K041161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2004
Decision Date May 03, 2005
Days to Decision 365 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
250d slower than avg
Panel avg: 115d · This submission: 365d
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 607
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K041161.
COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING
K043296 · Covalontechnologies, Inc. · Jun 2005
EPI-MAX
K041059 · Dermagenics, Inc. · May 2005
DERMACYN WOUND IRRIGATION
K042729 · Oculus Innovative Sciences, Inc. · May 2005
ACTICOAT MOISTURE CONTROL DRESSING
K050030 · Smith & Nephew, Inc. · Apr 2005
MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450
K033732 · Medtrade Products , Ltd. · Dec 2004
3M TEGADERM SILVER
K040890 · 3M Company · Nov 2004