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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 a medical device manufactured by Insightec, Inc.. It received FDA 510(k) clearance on 2021-11-23 under approval 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. It is manufactured by Insightec, Inc.. The 510(k) number is K212150.

When was Exablate Prostate System approved by the FDA?

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

What company makes Exablate Prostate System?

Exablate Prostate System is manufactured by Insightec, Inc..

What is the FDA product code for Exablate Prostate System?

The FDA product code for Exablate Prostate System is PLP.

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Official Source

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

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