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.

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
No devices found for this product code.

About Product Code NTB - Regulatory Context