K240480 is an FDA 510(k) clearance for the IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327), 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 review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K240480 FDA.gov |
| FDA Decision | Cleared 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 |