Microcyn Wound Care Dressing

• 2 recalls, same reason

  • Terminated Z-0448-2012 FDA Unclassified (pre-2012) ·initiated 9 Nov 2011
  • Terminated Z-0450-2012 FDA Unclassified (pre-2012) ·initiated 9 Nov 2011

  Unapproved drug claims and those not approved under 510K clearance.

510(k) Number

K041161 ↗

FDA Product Code

FRO

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Loyon

  Unclassified

  FDA 510(k) K162217 Active Cleared 23 Mar 2017

• Hydrocleanse Wound Care Solution

  Unclassified

  FDA 510(k) K141012 Active Cleared 8 Aug 2014

• Oculus Microcyn Wound Gel

  Unclassified

  FDA 510(k) K090725 Active Cleared 20 May 2009

• Microcyn Plus Wound Care Solution

  Unclassified

  FDA 510(k) K161034 Active Cleared 19 Aug 2016

• Microcyn Skin and Wound Hydrogel

  Unclassified

  FDA 510(k) K093585 Active Cleared 8 Mar 2010

• Alevicyn SG Antipruritic Gel

  Unclassified

  FDA 510(k) K143590 Active Cleared 4 Jun 2015

See all devices from Oculus Innovative Sciences →