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510(k) K060346

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

K060346 is an FDA 510(k) premarket notification submitted by Ultrazonix Dnt AB for the device "ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM". The FDA issued a decision of Substantially Equivalent on December 22, 2006. The device falls under product code NTB (System, Ablation, Ultrasound And Accessories), a Class II device regulated under 21 CFR 878.4400.

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)

FDA data resources