Device Classification Name |
cystoscope and accessories, flexible/rigid
|
510(k) Number |
K202957 |
Device Name |
Flexible Video Cysto-Urethroscope (C-view) |
Applicant |
KARL STORZ Endoscopy-America, Inc |
2151 E. Grand Avenue |
EI Segundo,
CA
90245
|
|
Applicant Contact |
Winkie Wong |
Correspondent |
KARL STORZ Endoscopy-America, Inc |
2151 E. Grand Avenue |
EI Segundo,
CA
90245
|
|
Correspondent Contact |
Winkie Wong |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/30/2020 |
Decision Date | 10/29/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|