Device Classification Name |
Ureteroscope And Accessories, Flexible/Rigid
|
510(k) Number |
K121112 |
Device Name |
STRYKER VIDEO URETEROSCOPE |
Applicant |
Stryker Endoscopy |
5900 OPTICAL CT. |
SAN JOSE,
CA
95138
|
|
Applicant Contact |
KEVIN POTGIETER, RAC |
Correspondent |
Stryker Endoscopy |
5900 OPTICAL CT. |
SAN JOSE,
CA
95138
|
|
Correspondent Contact |
KEVIN POTGIETER, RAC |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/12/2012 |
Decision Date | 09/12/2012 |
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
|
|
|