Cleared Traditional

K242687 - NanoKnife Generator (H78720300301US0)

Also marketed or referenced as:
NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090) NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100) NanoKnife Single Electrode Probe Spacer (H787204003010)

K242687 is the FDA 510(k) clearance for NanoKnife Generator (H78720300301US0) by AngioDynamics, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OAB) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

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 10
Devices cleared under the same product code (OAB) and FDA review panel - the closest regulatory comparables to K242687.
Aliya® EX System
K253826 · Galvanize Therapeutics, Inc. · May 2026
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
Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe
K222001 · Zhejiang Curaway Medical Technology Co., Ltd. · Jun 2023