NTBClass II

System, Ablation, Ultrasound And Accessories

21 CFR 878.4400 / General, Plastic Surgery

NTB is the FDA product code for System, Ablation, Ultrasound And Accessories, a class II device type, regulated under 21 CFR 878.4400. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 6 510(k) clearances under this code, the most recent dated 2016-01-13, and no recalls.

Classification record

Product code: NTB
Device name: System, Ablation, Ultrasound And Accessories
FDA 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.
Regulation: 21 CFR 878.4400
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 6
Ingested recalls: 0

Clearances, product code NTB

By decision year

6 clearances under product code NTB with a decision year between 2004 and 2016, 2004 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code NTB by decision year
Year	Clearances
2004	2
2006	2
2008	1
2016	1

Applicants with the most clearances

Product code NTB

Applicants holding the most 510(k) clearances under product code NTB
Applicant	Clearances
Epicor Medical, Inc.	2
Misonix, LLC	2
Acoustic Medsystems, Inc.	1
Ultrazonix Dnt AB	1

Companies listing this code with FDA

Companies whose registered establishments list this code