Sonablate
K-Number: K160942 · 2016-12-21
ApplicantSonacare Medical, LLC
Decision Date2016-12-21
Product CodePLP
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Sonablate is a medical device manufactured by Sonacare Medical, LLC. It received FDA 510(k) clearance on 2016-12-21 under approval 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. It is manufactured by Sonacare Medical, LLC. The 510(k) number is K160942.
When was Sonablate approved by the FDA?
Sonablate received FDA 510(k) clearance on 2016-12-21, under approval number K160942.
What company makes Sonablate?
Sonablate is manufactured by Sonacare Medical, LLC.
What is the FDA product code for Sonablate?
The FDA product code for Sonablate is PLP.
Related Devices (Code: PLP)
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.