Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device accessories, cleaning, for endoscope
Regulation Description Endoscope and accessories.
Product CodeFEB
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM ULTRASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
LANGFORD IC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDIVATORS REPROCESSING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
MINNTECH
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 107
Unknown (for use when the device problem is not known) 35
Use of Device Issue 23
Improper or incorrect procedure or method 17
No Known Device Problem 12
Fumes or vapors 6
Use of Incorrect Control Settings 6
Fire 6
Fluid leak 5
Device Rinsing Issue 5
Disinfection or Sterilization Issue at User Location 5
Temperature issue 5
Ventilation issue in device environment 3
Maintenance does not comply to manufacturers recommendations 3
Contamination during use 3
Break 3
Device Cleaning Issue 2
Component(s), worn 2
Decoupling 2
Disinfection, inadequate/improper 2
Insufficient heating 2
Smoking 2
Normal 2
Defective component 2
No Information 2
No code available 2
Chemical spillage 2
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Mechanics altered 1
Connection issue 1
Device disinfection or sterilization issue 1
Device displays error message 1
Bacterial contamination of device 1
Overfill 1
Electro-static discharge 1
Power Conditioning Issue 1
User used incorrect product for intended use 1
Reflux within device 1
Inappropriate shock 1
Metal shedding debris 1
Instruction for use issue 1
Device maintenance issue 1
Misassembled 1
Misconnection 1
Mislabeled 1
Shock, electrical 1
Grounding malfunction 1
Crack 1
Circuit Failure 1
Adaptor, failure of 1
Alarm, audible 1
Total Device Problems 291

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

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Sterilization Products II Apr-18-2013
2 Advanced Sterilization Products II Apr-15-2013
3 Advanced Sterilization Products II Nov-07-2008
4 Advanced Sterilization Products II Aug-08-2008
5 Custom Ultrasonics, Inc. II May-04-2007
6 Minntech Corp II Aug-12-2010

-
-