K253198 is an FDA 510(k) clearance for the NanoKnife Generator (H78720300351US0). This device is classified as a Low Energy Direct Current Thermal Ablation System (Class II - Special Controls, product code OAB).
Submitted by Angiodynamics (Marlborough, US). The FDA issued a Cleared decision on March 24, 2026, 179 days after receiving the submission on September 26, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.4400. Ablation Of Soft Tissue.
| 510(k) Number | K253198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2025 |
| Decision Date | March 24, 2026 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OAB - Low Energy Direct Current Thermal Ablation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Ablation Of Soft Tissue |