FDA 510(k)

Sonablate

K-Number: K160942 · 2016-12-21

Decision Date2016-12-21

Product CodePLP

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Sonablate is the device name listed in this FDA 510(k) record. The listed applicant is Sonacare Medical, LLC. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K160942. 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 Sonablate?

Sonablate is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Sonacare Medical, LLC. The 510(k) number is K160942.

When did Sonablate receive FDA 510(k) clearance?

Sonablate received FDA 510(k) clearance on 2016-12-21, under 510(k) number K160942.

Who is the listed applicant for Sonablate?

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

What is the FDA product code for Sonablate?

The FDA product code for Sonablate is PLP.

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.K212150Exablate Prostate SystemInsightec, Inc.

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.