FDA 510(k)

IMC HYPODERMIC NEEDLE

K-Number: K102584 · 2011-01-14

ApplicantInternational Medsurg Connection

Decision Date2011-01-14

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

IMC HYPODERMIC NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is International Medsurg Connection. It received FDA 510(k) clearance on 2011-01-14 under 510(k) number K102584. 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 IMC HYPODERMIC NEEDLE?

IMC HYPODERMIC NEEDLE is a medical device that received FDA 510(k) clearance on 2011-01-14. The listed applicant is International Medsurg Connection. The 510(k) number is K102584.

When did IMC HYPODERMIC NEEDLE receive FDA 510(k) clearance?

IMC HYPODERMIC NEEDLE received FDA 510(k) clearance on 2011-01-14, under 510(k) number K102584.

Who is the listed applicant for IMC HYPODERMIC NEEDLE?

The FDA 510(k) record lists International Medsurg Connection as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMC HYPODERMIC NEEDLE?

The FDA product code for IMC HYPODERMIC NEEDLE is FMI.

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Other records listing International Medsurg Connection as applicant

K110882IMC INSULIN SYRINGE K110656IMC BLOOD COLLECTION NEEDLE K102969IMC PISTON SYRINGES K100991IMC SURGICAL DRAPE K100846IMC SURGICAL FACE MASK K100208IMC SURGICAL DRAPE

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Related Devices (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.

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.