Angiodynamics · Class II · Cleared Mar 24, 2026
| K-number | K253198 |
| Device name | NanoKnife Generator (H78720300351US0) |
| Applicant | Angiodynamics |
| Product code | OAB |
| Device class | Class II |
| Decision date | Mar 24, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 878.4400 |
The NanoKnife Generator is a software-controlled low-energy direct-current (LEDC) device that surgically ablates soft tissue, including prostate tissue. It delivers adjustable voltage pulses between pairs of probes in a series, with probe placement and activation controlled by the clinician using a foot-pedal.
The proposed NanoKnife Generator has been updated with newly-selected components compared to the predicate NanoKnife Generator. Despite component differences, the overall design, principle of operation, energy output, mechanism of action, and performance parameters remain substantially equivalent between the two devices.
IEC 60601-1, IEC 60601-1-2, IEC 62304, ANSI C63.27, IEC TS 60601-4-2, ASTM D4169-22, ISO 15223-1. Testing included electrical safety, EMC, software validation, GUI regression testing, functional performance, hardware design verification, reliability verification, and packaging/labeling design verification.
View the full FDA submission: accessdata.fda.gov