• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device kit, wound dressing
Regulation Description Elastic bandage.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeMCY
Regulation Number 880.5075
Device Class 2


Premarket Reviews
ManufacturerDecision
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTINENTAL MEDICAL LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT - KIT 1
JOHNSON & JOHNSON
  1
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 1 0 1 0 0 1 0 0
Class II 0 1 0 0 2 1 0 0 1 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II May-27-2011
2 Centurion Medical Products Corporation I Mar-08-2011
3 Customed, Inc II Apr-14-2016
4 Customed, Inc II Sep-03-2015
5 Customed, Inc I Dec-16-2014
6 Customed, Inc II Mar-21-2012
7 Medela Inc II Sep-08-2011
8 Smith And Nephew, Inc. Wound Management Division II Mar-12-2008
9 Tri-State Hospital Supply Corporation I Mar-25-2009

-
-