NTB — System, Ablation, Ultrasound And Accessories Class II
FDA product code NTB covers "System, Ablation, Ultrasound And Accessories", a Class II medical device regulated under 21 CFR 878.4400. Submissions are reviewed by the General, Plastic Surgery panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NTB
- Device Class
- Class II
- Regulation Number
- 878.4400
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K150019 | acoustic medsystems | TheraVision Ultrasound Ablation System and ACOUSTx Applicators | January 13, 2016 |
| K070779 | misonix | SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM | July 9, 2008 |
| K060346 | ultrazonix dnt | ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM | December 22, 2006 |
| K042096 | misonix | MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM | January 26, 2006 |
| K040641 | epicor medical | ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, | May 5, 2004 |
| K022894 | epicor medical | EPICOR MEDICAL ABLATION SYSTEM | February 26, 2004 |