Device Classification Name |
stent, ureteral
|
510(k) Number |
K162109 |
Device Name |
Kwart Retro-Inject Ureteral Stent |
Applicant |
COOK INCORPORATED |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Applicant Contact |
KARA KANORR |
Correspondent |
COOK INCORPORATED |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Correspondent Contact |
KARA KANORR |
Regulation Number | 876.4620
|
Classification Product Code |
|
Date Received | 07/29/2016 |
Decision Date | 06/07/2017 |
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
|
Recalls |
CDRH Recalls
|
|
|