Device Classification Name |
Cystoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K202921 |
Device Name |
Uro-G Cystoscope |
Applicant |
UroViu Corporation |
5337 - 14th Place SE |
Bellevue,
WA
98006
|
|
Applicant Contact |
Thomas Lawson |
Correspondent |
UroViu Corporation |
5337 - 14th Place SE |
Bellevue,
WA
98006
|
|
Correspondent Contact |
Thomas Lawson |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/29/2020 |
Decision Date | 05/04/2021 |
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
|
|
|