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 K253568
Device Name Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR
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 100
Lexington,  MA  02421
Correspondent Contact Chaitrali Kulkarni
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
FDF  
Date Received11/17/2025
Decision Date 02/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-