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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number876.4340
Classification Product Code
PLP  
Date Received07/09/2021
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
Predetermined Change
Control Plan Authorized		 No
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