Device Classification Name |
Endoscopic Access Overtube, Gastroenterology-Urology
|
510(k) Number |
K172217 |
Device Name |
Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath |
Applicant |
Cook Incorporated |
750 Daniels Way |
Bloomington,
IN
47404
|
|
Applicant Contact |
Andrew Breidenbach |
Correspondent |
Cook Incorporated |
750 Daniels Way |
Bloomington,
IN
47404
|
|
Correspondent Contact |
Andrew Breidenbach |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/24/2017 |
Decision Date | 12/13/2017 |
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
|
|
|