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 Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K243091
Device Name Over-tube (TR-1108A)
Applicant
Fujifilm Corporation
798 Miyanodai Kaisei-Machi
Ashigara Kami-Gun,  JP 258-8538
Applicant Contact Chaitrali Kulkarni
Correspondent
Fujifilm Healthcare Americas Corporation
81 Hartwell Ave.
Suite 300
Lexington,  MA  02421
Correspondent Contact Chaitrali Kulkarni
Regulation Number876.1500
Classification Product Code
FED  
Date Received09/30/2024
Decision Date 11/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-