Device Classification Name |
High Intensity Ultrasound System For Prostate Tissue Ablation
|
510(k) Number |
K212150 |
Device Name |
Exablate Prostate System |
Applicant |
Insightec, Inc |
4851 LBJ Freeway, Suite 400 |
Dallas,
TX
75244
|
|
Applicant Contact |
Nadir Alikacem |
Correspondent |
Insightec, Inc |
4851 LBJ Freeway, Suite 400 |
Dallas,
TX
75244
|
|
Correspondent Contact |
Nadir Alikacem |
Regulation Number | 876.4340
|
Classification Product Code |
|
Date Received | 07/09/2021 |
Decision Date | 11/23/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01657942
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|