K192406 is an FDA 510(k) clearance for the AveCure BT Microwave Ablation System. This device is classified as a System, Ablation, Microwave And Accessories (Class II - Special Controls, product code NEY).
Submitted by Medwaves, Inc. (San Diego, US). The FDA issued a Cleared decision on November 25, 2020, 448 days after receiving the submission on September 4, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K192406 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2019 |
| Decision Date | November 25, 2020 |
| Days to Decision | 448 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NEY - System, Ablation, Microwave And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |