# K070779: Sonatherm 600I Ultrasonic Lesion Generating System

- Pathway: 510(k) (Traditional)
- Applicant: Misonix, Inc.
- Decided: Jul 9, 2008 after 476 days
- Product code: NTB (System, Ablation, Ultrasound And Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K926514 (1993). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042096: Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System, Misonix, Inc. (2006) Summary page 1.
- K002615: Surgical System with Cryoguide, Endocare, Inc. (2000) Summary page 1.
- K032333: Cryocare CS Surgical System, Endocare, Inc. (2003) Summary page 1.
- K050347: Modification to Cryocare CS Surgical System, Endocare, Inc. (2005) Summary page 1.

## Most influential descendants
- K150019: TheraVision Ultrasound Ablation System and ACOUSTx Applicators (2016), 0 descendants of its own

## Indications for use
The Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted ablation area in General Surgery. The Sonatherm is not to be used for non-invasive ablation, i.e. leaving intervening tissue spared, and it is not indicated for the ablation of Prostate tissue.

Source page: https://510kreport.com/device/K070779
Methodology: https://510kreport.com/methodology