FDA 510(k)

Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle

Numéro K : K222852 · 2023-05-25

Date de décision2023-05-25

Code produitFMI

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corporation. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K222852. 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 Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle?

Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Nipro Medical Corporation. The 510(k) number is K222852.

When did Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle receive FDA 510(k) clearance?

Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle received FDA 510(k) clearance on 2023-05-25, under 510(k) number K222852.

Who is the listed applicant for Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle?

The FDA 510(k) record lists Nipro Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle?

The FDA product code for Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle is FMI.

Essais cliniques associés

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Autres dossiers indiquant Nipro Medical Corporation 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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