Device Classification Name |
cystoscope and accessories, flexible/rigid
|
510(k) Number |
K182876 |
Device Name |
Uro-N 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 |
|
Subsequent Product Code |
|
Date Received | 10/12/2018 |
Decision Date | 07/02/2019 |
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
|
|
|