• 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 endoscopic central control unit
Regulation Description Endoscope and accessories.
Definition To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.
Product CodeODA
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 5
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 5
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Issue 1
Total Device Problems 1

-
-