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FDA 510(k)

Exablate Prostate System

K-Number: K212150 · 2021-11-23

ApplicantInsightec, Inc.
Decision Date2021-11-23
Product CodePLP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Exablate Prostate System is the device name listed in this FDA 510(k) record. The listed applicant is Insightec, Inc.. It received FDA 510(k) clearance on 2021-11-23 under 510(k) number K212150. The device is classified under product code PLP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exablate Prostate System?

Exablate Prostate System is a medical device that received FDA 510(k) clearance on 2021-11-23. The listed applicant is Insightec, Inc.. The 510(k) number is K212150.

When did Exablate Prostate System receive FDA 510(k) clearance?

Exablate Prostate System received FDA 510(k) clearance on 2021-11-23, under 510(k) number K212150.

Who is the listed applicant for Exablate Prostate System?

The FDA 510(k) record lists Insightec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Exablate Prostate System?

The FDA product code for Exablate Prostate System is PLP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02246374ExAblate Transcranial MRgFUS of the Subthalamic Nucleus for Treatment of Parkinson's DiseaseCOMPLETEDNCT03028246A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult SubjectsRECRUITINGNCT04002596Safety and Initial Effectiveness of Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's DiseaseCOMPLETEDNCT04197921Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)RECRUITINGNCT05317858Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain MetsRECRUITINGNCT07764874Unilateral and Staged Bilateral Pallidothalamic Tractotomy Using Exablate MRgFUS in Advanced Parkinson's Disease.NOT_YET_RECRUITING

Other records listing Insightec, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P150038MR-guided focused ultrasound systemPMA P040003Ablation system, high intensity focused ultrasound (HIFU), MR-guidedK231378Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0PMA P110039Ablation system, high intensity focused ultrasound (HIFU), MR-guided

Related Devices (Code: PLP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251910Focal One®Edap Technomed, Inc.K240296Tulsa Pro System (Pad-105)Profound Medical, Inc.K231378Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0Insightec, Ltd.K230692TULSA-PRO SystemProfound Medical, Inc.K211858TULSA-PRO SystemProfound Medical, Inc.K202286Tulsa-Pro SystemProfound Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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