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FDA 510(k)

Electroporation System (N3000)

K-Number: K240376 · 2024-10-04

ApplicantSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Decision Date2024-10-04
Product CodeOAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Electroporation System (N3000) is a medical device manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. It received FDA 510(k) clearance on 2024-10-04 under approval number K240376. 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 Electroporation System (N3000)?

Electroporation System (N3000) is a medical device that received FDA 510(k) clearance on 2024-10-04. It is manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. The 510(k) number is K240376.

When was Electroporation System (N3000) approved by the FDA?

Electroporation System (N3000) received FDA 510(k) clearance on 2024-10-04, under approval number K240376.

What company makes Electroporation System (N3000)?

Electroporation System (N3000) is manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd..

What is the FDA product code for Electroporation System (N3000)?

The FDA product code for Electroporation System (N3000) is OAB.

Related Clinical Trials

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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. 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.

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