K150019 is an FDA 510(k) clearance for the TheraVision Ultrasound Ablation System and ACOUSTx Applicators. This device is classified as a System, Ablation, Ultrasound And Accessories (Class II - Special Controls, product code NTB).
Submitted by Acoustic Medsystems, Inc. (Savoy, US). The FDA issued a Cleared decision on January 13, 2016, 373 days after receiving the submission on January 5, 2015.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. 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..
| 510(k) Number | K150019 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2015 |
| Decision Date | January 13, 2016 |
| Days to Decision | 373 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NTB — System, Ablation, Ultrasound And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| 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. |