K241827 is an FDA 510(k) clearance for the Microwave Ablation Generator (KY-2000A, KY-2100A), a System, Ablation, Microwave And Accessories (Class II — Special Controls, product code NEY), submitted by Canyon Medical, Inc. (Nanjing, CN). The FDA issued a Cleared decision on September 26, 2024, 94 days after receiving the submission on June 24, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K241827 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 24, 2024 |
| Decision Date | September 26, 2024 |
| Days to Decision | 94 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 |