FDA 510(k)

Verisafe Safety Sterile Needles (SSN)

Número K: K254273 · 2026-04-16

RequerentePromisemed Hangzhou Meditech Co., Ltd.

Data da decisão2026-04-16

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Verisafe Safety Sterile Needles (SSN) is the device name listed in this FDA 510(k) record. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2026-04-16 under 510(k) number K254273. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Verisafe Safety Sterile Needles (SSN)?

Verisafe Safety Sterile Needles (SSN) is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K254273.

When did Verisafe Safety Sterile Needles (SSN) receive FDA 510(k) clearance?

Verisafe Safety Sterile Needles (SSN) received FDA 510(k) clearance on 2026-04-16, under 510(k) number K254273.

Who is the listed applicant for Verisafe Safety Sterile Needles (SSN)?

The FDA 510(k) record lists Promisemed Hangzhou Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Verisafe Safety Sterile Needles (SSN)?

The FDA product code for Verisafe Safety Sterile Needles (SSN) is FMI.

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Outros registros que listam Promisemed Hangzhou Meditech Co., Ltd. como candidato(a)

K261719Promisemed X-Safety Pen Needle K261196Promisemed VeriEcto Automatic Biopsy Needles K261045Verifine Safety Lancets K250192Verisafe Safety Retractable Insulin Syringes K250961Blood collection tube holders K251138Promisemed Safety Huber Needles

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Dispositivos Relacionados (Código: 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.

Fonte oficial

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