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510(k) K150019

TheraVision Ultrasound Ablation System and ACOUSTx Applicators by Acoustic Medsystems, Inc. — Product Code NTB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2016
Date Received
January 5, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Ablation, Ultrasound And Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Intended for use as a surgical tool for coagulation and ablation of soft tissue. This differs from the description in the regulation in that this device is not intended to cut tissue and this device uses high intensity ultrasound energy instead of electrosurgery or electrocautery.

Other clearances by Acoustic Medsystems, Inc.

  • K131428 — RADVISION (July 16, 2013)

Other clearances for product code NTB

  • K070779 — SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM (July 9, 2008)
  • K060346 — ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM (December 22, 2006)
  • K042096 — MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM (January 26, 2006)
  • K040641 — ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, (May 5, 2004)
  • K022894 — EPICOR MEDICAL ABLATION SYSTEM (February 26, 2004)