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FDA 510(k)

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

K-Number: K222001 · 2023-06-08

ApplicantZhejiang Curaway Medical Technology Co., Ltd.
Decision Date2023-06-08
Product CodeOAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-06-08 under 510(k) number K222001. 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 Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe?

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe is a medical device that received FDA 510(k) clearance on 2023-06-08. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. The 510(k) number is K222001.

When did Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe receive FDA 510(k) clearance?

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe received FDA 510(k) clearance on 2023-06-08, under 510(k) number K222001.

Who is the listed applicant for Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe?

The FDA 510(k) record lists Zhejiang Curaway Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe?

The FDA product code for Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe 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.

NCT05501873Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation SystemACTIVE_NOT_RECRUITINGNCT06364215Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial FibrillationTERMINATEDNCT07021313Deliver mOre aPplications for More Durable Pulmonary Vein IsOlationACTIVE_NOT_RECRUITINGNCT07328243Irreversible Electroporation for Recurrent or Metastatic Cervical Lymph Node Metastases From Thyroid Cancer: A Prospective Multicenter Single-Arm StudyRECRUITINGNCT07638228Evaluation of the Safety and Efficacy of a Wideband Electric Pulse Tumor Ablation System for Malignant Pulmonary NodulesACTIVE_NOT_RECRUITINGNCT07721948Assessment of Catheter Tissue Contact in PFANOT_YET_RECRUITING

Other records listing Zhejiang Curaway Medical Technology Co., Ltd. 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.

K244018Disposable Biopsy NeedleK242322Bone Marrow Biopsy NeedleK241793Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy NeedleK240758Radiofrequency Generator System, Cura RF ElectrodeK232505Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter

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

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

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