Sonablate— 510(k) K160942

Substantially Equivalent

Sonacare Medical, LLC

FDA 510(k) clearance K160942 for Sonablate, Substantially Equivalent on 2016-12-21. Applicant: Sonacare Medical, LLC. Device class: 2.

Clearance details

Applicant: Sonacare Medical, LLC
Product code: Code PLP
Device class: Class 2
Regulation: 21 CFR 876.4340
Advisory panel: Gastroenterology, Urology
Date received: 2016-04-05
Decision date: 2016-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlotte, NC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.