Device Classification Name |
endoscopic access overtube, gastroenterology-urology
|
510(k) Number |
K160861 |
Device Name |
Proxis Ureteral Access Sheath |
Applicant |
C.R. Bard, Inc. |
8195 Industrial Blvd |
Covington,
GA
30014
|
|
Applicant Contact |
Beatrice Wan |
Correspondent |
THIRD PARTY REVIEW GROUP, LLC |
45 ROCKEFELLER PLAZA |
SUITE 2000 |
NEW YORK,
NY
10111
|
|
Correspondent Contact |
DAVE YUNGVIRT |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/29/2016 |
Decision Date | 03/31/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|