K172285 is an FDA 510(k) clearance for the Ablatherm Fusion. This device is classified as a High Intensity Ultrasound System For Prostate Tissue Ablation (Class II - Special Controls, product code PLP).
Submitted by Edap Technomed, Inc. (Austin, US). The FDA issued a Cleared decision on October 3, 2017, 67 days after receiving the submission on July 28, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4340. Prostate Tissue Ablation.
| 510(k) Number | K172285 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2017 |
| Decision Date | October 03, 2017 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PLP - High Intensity Ultrasound System For Prostate Tissue Ablation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4340 |
| Definition | Prostate Tissue Ablation |