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 gastroscope and accessories, flexible/rigid
Regulation Description Endoscope and accessories.
Definition To examine or perform procedures in the stomach.
Product CodeFDS
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 8
PENTAX
  SUBSTANTIALLY EQUIVALENT 4
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Cleaning Issue 34
No display or display failure 18
No Information 6
No Known Device Problem 5
Break 5
Use of Device Issue 3
Contamination during use 3
Device damaged prior to use 2
Defective component 2
No code available 2
Not Applicable 1
Bacterial contamination of device 1
Failure to advance 1
Physical resistance 1
Disinfection or Sterilization Issue at User Location 1
Dislodged or dislocated 1
Maintenance does not comply to manufacturers recommendations 1
Mechanical jam 1
Crack 1
Decrease in suction 1
Failure to disinfect 1
Device clogged 1
Accessory incompatible 1
Blockage within device or device component 1
Fluid leak 1
Loose or intermittent connection 1
Mechanical issue 1
Poor quality image 1
Decrease in pressure 1
Material puncture 1
Reflux within device 1
Material rupture 1
Device inoperable 1
Total Device Problems 103

-
-