Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use

Número K: K212857 · 2023-05-09

RequerenteJiangsu Zhiyu Medical Instrument Co, Ltd.
Data da decisão2023-05-09
Código do produtoFMF
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Zhiyu Medical Instrument Co, Ltd.. It received FDA 510(k) clearance on 2023-05-09 under 510(k) number K212857. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use?

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use is a medical device that received FDA 510(k) clearance on 2023-05-09. The listed applicant is Jiangsu Zhiyu Medical Instrument Co, Ltd.. The 510(k) number is K212857.

When did Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use receive FDA 510(k) clearance?

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use received FDA 510(k) clearance on 2023-05-09, under 510(k) number K212857.

Who is the listed applicant for Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use?

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

What is the FDA product code for Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use?

The FDA product code for Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use is FMF.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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.

↑