Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400) → NTB — System, Ablation, Ultrasound And Accessories

# NTB · System, Ablation, Ultrasound And Accessories

_General, Plastic Surgery · 21 CFR 878.4400 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NTB

## Overview

- **Product Code:** NTB
- **Device Name:** System, Ablation, Ultrasound And Accessories
- **Regulation:** [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **3rd-party reviewable:** yes

## Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

## Classification Rationale

Class II.

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K150019](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NTB/K150019.md) | TheraVision Ultrasound Ablation System and ACOUSTx Applicators | Acoustic Medsystems, Inc. | Jan 13, 2016 | SESE |
| [K070779](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NTB/K070779.md) | SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM | Misonix, Inc. | Jul 9, 2008 | SESE |
| [K060346](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NTB/K060346.md) | ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM | Ultrazonix Dnt AB | Dec 22, 2006 | SESE |
| [K042096](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NTB/K042096.md) | MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM | Misonix, Inc. | Jan 26, 2006 | SESE |
| [K040641](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NTB/K040641.md) | ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1 | Epicor Medical, Inc. | May 5, 2004 | SESE |
| [K022894](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NTB/K022894.md) | EPICOR MEDICAL ABLATION SYSTEM | Epicor Medical, Inc. | Feb 26, 2004 | SESE |

## Top Applicants

- Epicor Medical, Inc. — 2 clearances
- Misonix, Inc. — 2 clearances
- Acoustic Medsystems, Inc. — 1 clearance
- Ultrazonix Dnt AB — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NTB](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NTB)

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