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

510(k) Premarket Notification
  • 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 Classification Name duodenoscope and accessories, flexible/rigid
510(k) Number K202661
Device Name Evis Exera III Duodenovideoscope Olympus TJF-Q190V
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi,  JP 192-8507
Applicant Contact Toshiyuki Nakajima
Correspondent
Olympus Corporation of the Americas
3500 Corporate Parkway PO Box 610
Center Valley,  PA  18034 -0610
Correspondent Contact Sheri L. Musgnung
Regulation Number876.1500
Classification Product Code
FDT  
Subsequent Product Codes
FEB   NWB  
Date Received09/14/2020
Decision Date 12/08/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-