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FDA 510(k)

NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)

K-Number: K242687 · 2024-12-06

ApplicantAngioDynamics, Inc.
Decision Date2024-12-06
Product CodeOAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K242687. 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 (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)?

NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K242687.

When did NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) receive FDA 510(k) clearance?

NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) received FDA 510(k) clearance on 2024-12-06, under 510(k) number K242687.

Who is the listed applicant for NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)?

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

What is the FDA product code for NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)?

The FDA product code for NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) is OAB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04229563Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery DiseaseCOMPLETEDNCT04972097Pivotal Study of the NanoKnife System for the Ablation of Prostate TissueCOMPLETEDNCT07640776Irreversible Electroporation (IRE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)NOT_YET_RECRUITING

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Related Devices (Code: OAB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.K253198NanoKnife Generator (H78720300351US0)AngiodynamicsK240376Electroporation 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.

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