FDA 510(k)

NanoKnife Generator (H78720300351US0)

K-Number: K253198 · 2026-03-24

Decision Date2026-03-24

Product CodeOAB

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

NanoKnife Generator (H78720300351US0) is the device name listed in this FDA 510(k) record. The listed applicant is Angiodynamics. It received FDA 510(k) clearance on 2026-03-24 under 510(k) number K253198. The device is classified under product code OAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NanoKnife Generator (H78720300351US0)?

NanoKnife Generator (H78720300351US0) is a medical device that received FDA 510(k) clearance on 2026-03-24. The listed applicant is Angiodynamics. The 510(k) number is K253198.

When did NanoKnife Generator (H78720300351US0) receive FDA 510(k) clearance?

NanoKnife Generator (H78720300351US0) received FDA 510(k) clearance on 2026-03-24, under 510(k) number K253198.

Who is the listed applicant for NanoKnife Generator (H78720300351US0)?

The FDA 510(k) record lists Angiodynamics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NanoKnife Generator (H78720300351US0)?

The FDA product code for NanoKnife Generator (H78720300351US0) is OAB.

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Related Devices (Code: OAB)

K253846Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02)Hangzhou Ruidi Biotechnology , Ltd.K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc.K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)AngioDynamics, Inc.K240376Electroporation System (N3000)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.K240297Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.