NTB

System, Ablation, Ultrasound And Accessories

Product code

NTB

Device name

System, Ablation, Ultrasound And Accessories

Device class

Class 2

21 CFR

21 CFR 878.4400

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

6 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).