# K183385: NanoKnife System

- Pathway: 510(k) (Traditional)
- Applicant: Angiodynamics
- Decided: Jun 18, 2019 after 194 days
- Product code: OAB (Low Energy Direct Current Thermal Ablation System)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K942299 (1995). 49 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150089: NanoKnife System, AngioDynamics, Inc. (2015) Summary page 4.

## Most influential descendants
- K212871: Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) Electrode (2022), 2 descendants of its own
- 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) (2024), 1 descendant of its own
- K233884: INUMI™ Flex Needle (2024), 1 descendant of its own
- K253846: Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02) (2026), 0 descendants of its own
- K253826: Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle (2026), 0 descendants of its own

## Recalls of this device
- Mar 2, 2023 · Class II · Z-1381-2023: Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in p

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

Source page: https://510kreport.com/device/K183385
Methodology: https://510kreport.com/methodology