Device Classification Name |
Cystoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K182723 |
Device Name |
Flexible HD Cysto-Urethroscope System |
Applicant |
KARL STORZ Endoscopy-America, Inc. |
2151 E. Grand Avenue |
El Segundo,
CA
90245
|
|
Applicant Contact |
Nozomi Yagi |
Correspondent |
KARL STORZ Endoscopy-America, Inc. |
2151 E. Grand Avenue |
El Segundo,
CA
90245
|
|
Correspondent Contact |
Nozomi Yagi |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/28/2018 |
Decision Date | 04/23/2019 |
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
|
|
|