FDA 510(k)

Sterile syringes for single use with/without needle

Numéro K : K231729 · 2023-09-08

DemandeurWepon Medical Technology Co., Ltd.

Date de décision2023-09-08

Code produitFMI

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Sterile syringes for single use with/without needle is the device name listed in this FDA 510(k) record. The listed applicant is Wepon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K231729. 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 syringes for single use with/without needle?

Sterile syringes for single use with/without needle is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Wepon Medical Technology Co., Ltd.. The 510(k) number is K231729.

When did Sterile syringes for single use with/without needle receive FDA 510(k) clearance?

Sterile syringes for single use with/without needle received FDA 510(k) clearance on 2023-09-08, under 510(k) number K231729.

Who is the listed applicant for Sterile syringes for single use with/without needle?

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

What is the FDA product code for Sterile syringes for single use with/without needle?

The FDA product code for Sterile syringes for single use with/without needle is FMI.

Essais cliniques associés

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

K231723Sterile Safety Hypodermic Needles for Single Use K231727Sterile Auto-Disable Syringes with/without Needle for Single Use K231720Sterile Hypodermic Needles for Single Use K212299Medical Surgical Mask

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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