# K253198: NanoKnife Generator (H78720300351US0)

- Pathway: 510(k) (Traditional)
- Applicant: Angiodynamics
- Decided: Mar 24, 2026 after 179 days
- Product code: OAB (Low Energy Direct Current Thermal Ablation System)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K942299 (1995). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242687: NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010), AngioDynamics, Inc. (2024) Summary page 5.

## Indications for use
The NanoKnife System with six outputs is indicated for surgical ablation of soft tissue, including prostate tissue.

Source page: https://510kreport.com/device/K253198
Methodology: https://510kreport.com/methodology