K042096 is an FDA 510(k) clearance for the MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM. This device is classified as a System, Ablation, Ultrasound And Accessories (Class II - Special Controls, product code NTB).
Submitted by Misonix, Inc. (Farmingdale, US). The FDA issued a Cleared decision on January 26, 2006, 540 days after receiving the submission on August 4, 2004.
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 | K042096 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2004 |
| Decision Date | January 26, 2006 |
| Days to Decision | 540 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. |