FDA 510(k)

Hypodermic Needle-Pro EDGE Safety Device

Numéro K : K211634 · 2021-08-26

Date de décision2021-08-26

Code produitFMI

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Hypodermic Needle-Pro EDGE Safety Device is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2021-08-26 under 510(k) number K211634. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Hypodermic Needle-Pro EDGE Safety Device?

Hypodermic Needle-Pro EDGE Safety Device is a medical device that received FDA 510(k) clearance on 2021-08-26. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K211634.

When did Hypodermic Needle-Pro EDGE Safety Device receive FDA 510(k) clearance?

Hypodermic Needle-Pro EDGE Safety Device received FDA 510(k) clearance on 2021-08-26, under 510(k) number K211634.

Who is the listed applicant for Hypodermic Needle-Pro EDGE Safety Device?

The FDA 510(k) record lists Smiths Medical Asd, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hypodermic Needle-Pro EDGE Safety Device?

The FDA product code for Hypodermic Needle-Pro EDGE Safety Device is FMI.

Essais cliniques associés

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Autres dossiers indiquant Smiths Medical Asd, Inc. en tant que demandeur

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Dispositifs connexes (Code : 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.

Source officielle

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