Cleared Traditional

K242687 - NanoKnife Generator (H78720300301US0) (FDA 510(k) Clearance)

Also includes:
NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090) NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100) NanoKnife Single Electrode Probe Spacer (H787204003010)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K242687 · AngioDynamics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
91d
Days
Class 2
Risk

K242687 is an FDA 510(k) clearance for the NanoKnife Generator (H78720300301US0). Classified as Low Energy Direct Current Thermal Ablation System (product code OAB), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Marlborough, US). The FDA issued a Cleared decision on December 6, 2024 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.4400 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all AngioDynamics, Inc. devices

Submission Details

510(k) Number K242687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 130d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OAB Low Energy Direct Current Thermal Ablation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Ablation Of Soft Tissue
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04972097 Completed Interventional Industry-sponsored

Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue

Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue in an Intermediate-Risk Patient Population

121
Patients (actual)
17
Sites
Treatment
Purpose
Open label
Masking
Condition studied Prostate Cancer
Study design Single group
Eligibility Male only · 50 Years+
Principal investigator Jonathan Coleman, MD
Sponsor Angiodynamics, Inc. (industry)
Started 2022-03-29 → Primary completion 2024-08-14
Primary outcome
Rate of negative in-field biopsy at 12 months
Secondary outcome
Rate of negative in-field biopsy at 12 months as defined by the Delphi consensus criterion
Study completed - no results published. This trial concluded in 2024 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - OAB Low Energy Direct Current Thermal Ablation System

All 12
Devices cleared under the same product code (OAB) and FDA review panel - the closest regulatory comparables to K242687.
NanoKnife Generator (H78720300351US0)
K253198 · Angiodynamics · Mar 2026
Electroporation System (N3000)
K240376 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Oct 2024
INUMI™ Flex Needle
K233884 · Galvanize Therapeutics, Inc. · May 2024
Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)
K240297 · Us Medical Innovations, LLC · May 2024