Device Classification Name |
Cystoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K212202 |
Device Name |
WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System |
Applicant |
OTU Medical INC. |
2231 A Fortune Drive |
San Jose,
CA
95131
|
|
Applicant Contact |
Geping Liu |
Correspondent |
Zi-medical, Inc. |
93 Springs Rd |
Bedford,
MA
01730
|
|
Correspondent Contact |
Mingzi Hussey |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/14/2021 |
Decision Date | 04/13/2022 |
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
|
|
|