NTB · Class II · 21 CFR 878.4400

FDA Product Code NTB: System, Ablation, Ultrasound And Accessories

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.

Leading manufacturers include Misonix, Inc., Ultrazonix Dnt AB and Acoustic Medsystems, Inc..

6
Total
6
Cleared
384d
Avg days
2004
Since

FDA 510(k) Cleared System, Ablation, Ultrasound And Accessories Devices (Product Code NTB)

6 devices
1–6 of 6
Cleared Jan 13, 2016
TheraVision Ultrasound Ablation System and ACOUSTx Applicators
K150019
Acoustic Medsystems, Inc.
General & Plastic Surgery · 373d
Cleared Jul 09, 2008
SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM
K070779
Misonix, Inc.
General & Plastic Surgery · 476d
Cleared Dec 22, 2006
ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM
K060346
Ultrazonix Dnt AB
General & Plastic Surgery · 315d
Cleared Jan 26, 2006
MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM
K042096
Misonix, Inc.
General & Plastic Surgery · 540d

About Product Code NTB - Regulatory Context