FDA 510(k)

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

Número K: K222001 · 2023-06-08

RequerenteZhejiang Curaway Medical Technology Co., Ltd.

Data da decisão2023-06-08

Código do produtoOAB

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Zhejiang Curaway Medical Technology Co., Ltd. como candidato(a)

K260517Automatic Core Biopsy Instrument K244018Disposable Biopsy Needle K242322Bone Marrow Biopsy Needle K241793Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle K240758Radiofrequency Generator System, Cura RF Electrode K232505Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter

Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: OAB)

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.K253826Sistema Aliya® EX; Gerador Aliya® EX; Agulha Aliya®; Eletródo Aliya®; Agulha Flex INUMI™Galvanize Therapeutics, Inc.K253198NanoKnife Generator (H78720300351US0)Angiodynamics 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.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.