FDA 510(k)

Sterile Hypodermic Needles for Single Use

Numéro K : K223334 · 2022-12-16

DemandeurZhejiang Kindly Medical Devices Co., Ltd.

Date de décision2022-12-16

Code produitFMI

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Sterile Hypodermic Needles for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Kindly Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-12-16 under 510(k) number K223334. 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 Sterile Hypodermic Needles for Single Use?

Sterile Hypodermic Needles for Single Use is a medical device that received FDA 510(k) clearance on 2022-12-16. The listed applicant is Zhejiang Kindly Medical Devices Co., Ltd.. The 510(k) number is K223334.

When did Sterile Hypodermic Needles for Single Use receive FDA 510(k) clearance?

Sterile Hypodermic Needles for Single Use received FDA 510(k) clearance on 2022-12-16, under 510(k) number K223334.

Who is the listed applicant for Sterile Hypodermic Needles for Single Use?

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

What is the FDA product code for Sterile Hypodermic Needles for Single Use?

The FDA product code for Sterile Hypodermic Needles for Single Use is FMI.

Essais cliniques associés

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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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