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510(k) K160942

Sonablate by Sonacare Medical, LLC — Product Code PLP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2016
Date Received
April 5, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
High Intensity Ultrasound System For Prostate Tissue Ablation
Device Class
Class II
Regulation Number
876.4340
Review Panel
GU
Submission Type

Prostate tissue ablation

Other clearances by Sonacare Medical, LLC

  • DEN150011 — Sonablate 450 (October 9, 2015)

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