510(k) K060346

ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM by Ultrazonix Dnt AB — Product Code NTB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 22, 2006
Date Received: February 10, 2006
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 for product code NTB

K150019 — TheraVision Ultrasound Ablation System and ACOUSTx Applicators (January 13, 2016)
K070779 — SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM (July 9, 2008)
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)