Cleared Traditional

K253198 - NanoKnife Generator (H78720300351US0) (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253198 · Angiodynamics · Gastroenterology & Urology device
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Mar 2026
Decision
179d
Days
Class 2
Risk

K253198 is an FDA 510(k) clearance for the NanoKnife Generator (H78720300351US0). Classified as Low Energy Direct Current Thermal Ablation System (product code OAB), Class II - Special Controls.

Submitted by Angiodynamics (Marlborough, US). The FDA issued a Cleared decision on March 24, 2026 after a review of 179 days - an extended review cycle.

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 devices

Submission Details

510(k) Number K253198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2025
Decision Date March 24, 2026
Days to Decision 179 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
49d slower than avg
Panel avg: 130d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

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 K253198.
NanoKnife Generator (H78720300301US0)
K242687 · AngioDynamics, Inc. · Dec 2024
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
Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
K212871 · Galvanize Therapeutics, Inc. · Jun 2022