Device Classification Name |
ureteroscope and accessories, flexible/rigid
|
510(k) Number |
K213334 |
Device Name |
Monarch Platform, Urology |
Applicant |
Auris Health Inc |
150 Shoreline Drive |
Redwood City,
CA
94065
|
|
Applicant Contact |
Angela Wong |
Correspondent |
Auris Health Inc |
150 Shoreline Drive |
Redwood City,
CA
94065
|
|
Correspondent Contact |
Angela Wong |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/06/2021 |
Decision Date | 04/29/2022 |
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
|
|
|