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 Gastroscope And Accessories, Flexible/Rigid
510(k) Number K260824
Device Name Gastrointestinal Videoscope Olympus GIF-2T1500
Applicant
Olympus Medical Systems Corporation
2951 Ishikawa-Cho
Hachioji-Shi,  JP 192-8507
Applicant Contact Shinichiro Kawachi
Correspondent
Olympus Corporation of the Americas
800 W. Park Dr.
Westborough,  MA  01581
Correspondent Contact Brenda Geary
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
NWB  
Date Received03/13/2026
Decision Date 08/27/2026
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
Predetermined Change
Control Plan Authorized		 No
-
-