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FDA 510(k)

NanoKnife System

K-Number: K183385 · 2019-06-18

ApplicantAngiodynamics
Decision Date2019-06-18
Product CodeOAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NanoKnife System is the device name listed in this FDA 510(k) record. The listed applicant is Angiodynamics. It received FDA 510(k) clearance on 2019-06-18 under 510(k) number K183385. 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 System?

NanoKnife System is a medical device that received FDA 510(k) clearance on 2019-06-18. The listed applicant is Angiodynamics. The 510(k) number is K183385.

When did NanoKnife System receive FDA 510(k) clearance?

NanoKnife System received FDA 510(k) clearance on 2019-06-18, under 510(k) number K183385.

Who is the listed applicant for NanoKnife System?

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 System?

The FDA product code for NanoKnife System is OAB.

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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

Other records listing Angiodynamics as applicant

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.

K253198NanoKnife Generator (H78720300351US0)K252509AlphaVac Multipurpose Mechanical Aspiration System F1885K253106AngioVac CannulaK242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)K240397AlphaVac MMA F1885 System (H787253020)K231945VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits

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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)AngiodynamicsK242687NanoKnife 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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