510(k) K150019
K150019 is an FDA 510(k) premarket notification submitted by Acoustic Medsystems, Inc. for the device "TheraVision Ultrasound Ablation System and ACOUSTx Applicators". The FDA issued a decision of Substantially Equivalent on January 13, 2016. The device falls under product code NTB (System, Ablation, Ultrasound And Accessories), a Class II device regulated under 21 CFR 878.4400. Acoustic Medsystems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2016
- Date Received
- January 5, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Ablation, Ultrasound And Accessories
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
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.