Device Classification Name |
Duodenoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K191747 |
FOIA Releasable 510(k) |
K191747
|
Device Name |
FUJIFILM Duodenoscope Model ED-580XT |
Applicant |
FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi |
Ashigarakami-Gun,
JP
258-8538
|
|
Applicant Contact |
Randy Vader |
Correspondent |
FUJIFILM Medical Systems U.S.A., Inc. |
81 Hartwell Avenue, Suite 300 |
Lexington,
MA
02421
|
|
Correspondent Contact |
Kamila Sak |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/01/2019 |
Decision Date | 09/27/2019 |
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
|
|
|