Device Classification Name |
high intensity ultrasound system for prostate tissue ablation
|
510(k) Number |
K191200 |
Device Name |
TULSA-PRO System |
Applicant |
PROFOUND MEDICAL INC. |
2400 Skymark Avenue, Unit #6 |
Mississauga,
CA
L4W5K5
|
|
Applicant Contact |
Goldy Singh |
Correspondent |
PROFOUND MEDICAL INC. |
2400 Skymark Avenue, Unit #6 |
Mississauga,
CA
L4W5K5
|
|
Correspondent Contact |
Goldy Singh |
Regulation Number | 876.4340
|
Classification Product Code |
|
Date Received | 05/06/2019 |
Decision Date | 08/15/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01686958 NCT02766543
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|