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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 a medical device manufactured by Zhejiang Curaway Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-06-08 under approval 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. It is manufactured by Zhejiang Curaway Medical Technology Co., Ltd.. The 510(k) number is K222001.

When was Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe approved by the FDA?

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

What company makes Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe?

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe is manufactured by Zhejiang Curaway Medical Technology Co., Ltd..

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

NCT05501873 Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System ACTIVE_NOT_RECRUITING NCT06364215 Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation TERMINATED NCT05159492 Ground-Breaking Electroporation-based Intervention for PAROXysmal Atrial Fibrillation Treatment (BEAT PAROX-AF) COMPLETED NCT07429214 A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF RECRUITING NCT07548164 Comparing Two Different Boost Approaches in Radiation Therapy for People With Prostate Cancer RECRUITING NCT06106594 VOLT CE Mark Study ACTIVE_NOT_RECRUITING

Other Devices by Zhejiang Curaway Medical Technology Co., Ltd.

K240758Radiofrequency Generator System, Cura RF Electrode K232505Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter K244018Disposable Biopsy Needle K242322Bone Marrow Biopsy Needle K241793Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle

Related Devices (Code: OAB)

K183385NanoKnife SystemAngiodynamics K212871Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) ElectrodeGalvanize Therapeutics, Inc. 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. 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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