• 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 brush, biopsy, bronchoscope (non-rigid)
Regulation Description Bronchoscope (flexible or rigid) and accessories.
Product CodeBTG
Regulation Number 874.4680
Device Class 2


Premarket Reviews
ManufacturerDecision
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 4
Mislabeled 4
Break 3
Retraction problem 3
Failure to advance 3
User used incorrect product for intended use 2
No Known Device Problem 1
Torn material 1
Total Device Problems 21

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


-
-