FDA 510(k)

Disposable Insulin Pen Needle

Número K: K221178 · 2022-11-17

RequerenteNingbo Medsun Medical Co., Ltd.

Data da decisão2022-11-17

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Insulin Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Medsun Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K221178. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Insulin Pen Needle?

Disposable Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Ningbo Medsun Medical Co., Ltd.. The 510(k) number is K221178.

When did Disposable Insulin Pen Needle receive FDA 510(k) clearance?

Disposable Insulin Pen Needle received FDA 510(k) clearance on 2022-11-17, under 510(k) number K221178.

Who is the listed applicant for Disposable Insulin Pen Needle?

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

What is the FDA product code for Disposable Insulin Pen Needle?

The FDA product code for Disposable Insulin Pen Needle is FMI.

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 Medsun Medical Co., Ltd. como candidato(a)

K253622Safety Pen Needle K253605Safety Heel Lancet K242627Safety Lancet K242316Safety Lancet K232330Lancing System K222090Safety Lancet

Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT 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.