Device Classification Name |
Ureteroscope And Accessories, Flexible/Rigid
|
510(k) Number |
K181977 |
Device Name |
WiScope Digital Endoscope System |
Applicant |
OTU Medical Inc. |
2231A Fortune Drive |
San Jose,
CA
95131
|
|
Applicant Contact |
Doris Dong |
Correspondent |
THIRD PARTY REVIEW GROUP, LLC |
25 Independence Blvd |
Warren,
NJ
07059
|
|
Correspondent Contact |
David Yungvirt |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/24/2018 |
Decision Date | 08/14/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|