Exablate Prostate System— 510(k) K212150

Substantially Equivalent

Insightec, Inc.

FDA 510(k) clearance K212150 for Exablate Prostate System, Substantially Equivalent on 2021-11-23. Applicant: Insightec, Inc..

Clearance details

Applicant: Insightec, Inc.
Product code: Code PLP
Advisory panel: Gastroenterology, Urology
Date received: 2021-07-09
Decision date: 2021-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

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