FDA 510(k)

Disposable Injection Needles

Número K: K232200 · 2024-04-12

RequerenteNingbo Xinwell Medical Technology Co., Ltd.

Data da decisão2024-04-12

Código do produtoFBK

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Injection Needles is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Xinwell Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-04-12 under 510(k) number K232200. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Injection Needles?

Disposable Injection Needles is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Ningbo Xinwell Medical Technology Co., Ltd.. The 510(k) number is K232200.

When did Disposable Injection Needles receive FDA 510(k) clearance?

Disposable Injection Needles received FDA 510(k) clearance on 2024-04-12, under 510(k) number K232200.

Who is the listed applicant for Disposable Injection Needles?

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

What is the FDA product code for Disposable Injection Needles?

The FDA product code for Disposable Injection Needles is FBK.

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 Ningbo Xinwell Medical Technology Co., Ltd. como candidato(a)

K232969Disposable Hemostatic Clips

Dispositivos Relacionados (Código: FBK)

K260262Injection NeedleMirco-Tech (Nanjing) Co., Ltd.K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)Olympus Medical Systems Corporation K241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.K240675Endoscopic Injection NeedlesPromisemed Hangzhou Meditech Co., 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.