K240480 is an FDA 510(k) clearance for the IntelliBlate Microwave Ablation System Console (IB-CON). This device is classified as a System, Ablation, Microwave And Accessories (Class II - Special Controls, product code NEY).
Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on July 19, 2024, 150 days after receiving the submission on February 20, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K240480 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2024 |
| Decision Date | July 19, 2024 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEY — System, Ablation, Microwave And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |