FDA 510(k)

Promisemed X-Safety Pen Needle

K-Nummer: K261719 · 2026-08-25

AntragstellerPromisemed Hangzhou Meditech Co., Ltd.

Entscheidungsdatum2026-08-25

ProduktcodeFMI

BeratungsausschussHO

EntscheidungSubstantially Equivalent

Produktübersicht

Promisemed X-Safety Pen Needle 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 2026-08-25 under 510(k) number K261719. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Promisemed X-Safety Pen Needle?

Promisemed X-Safety Pen Needle is a medical device that received FDA 510(k) clearance on 2026-08-25. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K261719.

When did Promisemed X-Safety Pen Needle receive FDA 510(k) clearance?

Promisemed X-Safety Pen Needle received FDA 510(k) clearance on 2026-08-25, under 510(k) number K261719.

Who is the listed applicant for Promisemed X-Safety Pen Needle?

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 Promisemed X-Safety Pen Needle?

The FDA product code for Promisemed X-Safety Pen Needle is FMI.

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Verwandte Geräte (Code: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD 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.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.

Offizielle Quelle

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