Cleared Traditional

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)

K242687 · AngioDynamics, Inc. · Gastroenterology & Urology

Dec 2024

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K242687 is an FDA 510(k) clearance for the 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), a Low Energy Direct Current Thermal Ablation System (Class II — Special Controls, product code OAB), submitted by AngioDynamics, Inc. (Marlborough, US). The FDA issued a Cleared decision on December 6, 2024, 91 days after receiving the submission on September 6, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K242687 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 2024
Decision Date	December 06, 2024
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

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