FDA 510(k)

Safety Pen Needle for Single Use, Insulin Pen Needles

Numéro K : K212514 · 2022-04-29

DemandeurBerpu Medical Technology Co., Ltd.

Date de décision2022-04-29

Code produitFMI

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Safety Pen Needle for Single Use, Insulin Pen Needles is the device name listed in this FDA 510(k) record. The listed applicant is Berpu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K212514. 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 Safety Pen Needle for Single Use, Insulin Pen Needles?

Safety Pen Needle for Single Use, Insulin Pen Needles is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Berpu Medical Technology Co., Ltd.. The 510(k) number is K212514.

When did Safety Pen Needle for Single Use, Insulin Pen Needles receive FDA 510(k) clearance?

Safety Pen Needle for Single Use, Insulin Pen Needles received FDA 510(k) clearance on 2022-04-29, under 510(k) number K212514.

Who is the listed applicant for Safety Pen Needle for Single Use, Insulin Pen Needles?

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

What is the FDA product code for Safety Pen Needle for Single Use, Insulin Pen Needles?

The FDA product code for Safety Pen Needle for Single Use, Insulin Pen Needles is FMI.

Essais cliniques associés

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Autres dossiers indiquant Berpu Medical Technology Co., Ltd. en tant que demandeur

K232165Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles K221045Insulin Syringes without needle K220061Safety Insulin Syringes K213158Syringe with permanently attached needle K213811Sterile Hypodermic Syringes for Single Use K181447Safety insulin needle for single use

Voir tous les 9 dispositifs →

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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