FDA 510(k)

MONOJECT SAFETY NEEDLE

K-Number: K012736 · 2001-10-25

Decision Date2001-10-25

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MONOJECT SAFETY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Tyco Healthcare. It received FDA 510(k) clearance on 2001-10-25 under 510(k) number K012736. 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 MONOJECT SAFETY NEEDLE?

MONOJECT SAFETY NEEDLE is a medical device that received FDA 510(k) clearance on 2001-10-25. The listed applicant is Tyco Healthcare. The 510(k) number is K012736.

When did MONOJECT SAFETY NEEDLE receive FDA 510(k) clearance?

MONOJECT SAFETY NEEDLE received FDA 510(k) clearance on 2001-10-25, under 510(k) number K012736.

Who is the listed applicant for MONOJECT SAFETY NEEDLE?

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

What is the FDA product code for MONOJECT SAFETY NEEDLE?

The FDA product code for MONOJECT SAFETY NEEDLE is FMI.

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Other records listing Tyco Healthcare as applicant

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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.