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FDA 510(k)

PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110

K-Number: K063450 · 2007-01-25

ApplicantSmiths Medical Asd, Inc.
Decision Date2007-01-25
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110 is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2007-01-25 under 510(k) number K063450. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110?

PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110 is a medical device that received FDA 510(k) clearance on 2007-01-25. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K063450.

When did PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110 receive FDA 510(k) clearance?

PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110 received FDA 510(k) clearance on 2007-01-25, under 510(k) number K063450.

Who is the listed applicant for PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110?

The FDA 510(k) record lists Smiths Medical Asd, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110?

The FDA product code for PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110 is FMI.

Related Clinical Trials

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Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed 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.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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