NTB · System, Ablation, Ultrasound And Accessories
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | NTB |
|---|---|
| Device Name | System, Ablation, Ultrasound And Accessories |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 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 | TheraVision Ultrasound Ablation System and ACOUSTx Applicators | Acoustic Medsystems, Inc. | Jan 13, 2016 | SESE |
| K070779 | SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM | Misonix, Inc. | Jul 9, 2008 | SESE |
| K060346 | ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM | Ultrazonix Dnt AB | Dec 22, 2006 | SESE |
| K042096 | MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM | Misonix, Inc. | Jan 26, 2006 | SESE |
| K040641 | 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 | 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
