FDA 510(k)

SteriCap Mini Needle and Standard Needles

Número K: K212805 · 2021-09-30

Data da decisão2021-09-30

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

SteriCap Mini Needle and Standard Needles is the device name listed in this FDA 510(k) record. The listed applicant is Ocuject, LLC. It received FDA 510(k) clearance on 2021-09-30 under 510(k) number K212805. 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 SteriCap Mini Needle and Standard Needles?

SteriCap Mini Needle and Standard Needles is a medical device that received FDA 510(k) clearance on 2021-09-30. The listed applicant is Ocuject, LLC. The 510(k) number is K212805.

When did SteriCap Mini Needle and Standard Needles receive FDA 510(k) clearance?

SteriCap Mini Needle and Standard Needles received FDA 510(k) clearance on 2021-09-30, under 510(k) number K212805.

Who is the listed applicant for SteriCap Mini Needle and Standard Needles?

The FDA 510(k) record lists Ocuject, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SteriCap Mini Needle and Standard Needles?

The FDA product code for SteriCap Mini Needle and Standard Needles 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 Ocuject, LLC como candidato(a)

K242956LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle K233343SteriCap Safety Needle; VitreJect Safety Needle K230959VitreJect® Needle; OcuSafe® Needle K230372VitreJect Syringe K212544MiniLoad Syringe K202432MiniLoad Syringe

Ver todos os 8 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.