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FDA 510(k)

NanoKnife Generator (H78720300351US0)

K-Number: K253198 · 2026-03-24

ApplicantAngiodynamics
Decision Date2026-03-24
Product CodeOAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NanoKnife Generator (H78720300351US0) is a medical device manufactured by Angiodynamics. It received FDA 510(k) clearance on 2026-03-24 under approval 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. It is manufactured by Angiodynamics. The 510(k) number is K253198.

When was NanoKnife Generator (H78720300351US0) approved by the FDA?

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

What company makes NanoKnife Generator (H78720300351US0)?

NanoKnife Generator (H78720300351US0) is manufactured by Angiodynamics.

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

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

Related Clinical Trials

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Other Devices by Angiodynamics

K183385NanoKnife System

Related Devices (Code: OAB)

K183385NanoKnife SystemAngiodynamics K212871Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) ElectrodeGalvanize Therapeutics, Inc. K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeZhejiang Curaway Medical Technology Co., Ltd. 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.

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.

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