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FDA 510(k)

NEEDLE GUARD(TM)

K-Number: K890473 · 1989-04-03

ApplicantMartech Medical Products, Inc.
Decision Date1989-04-03
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEEDLE GUARD(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Martech Medical Products, Inc.. It received FDA 510(k) clearance on 1989-04-03 under 510(k) number K890473. 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 NEEDLE GUARD(TM)?

NEEDLE GUARD(TM) is a medical device that received FDA 510(k) clearance on 1989-04-03. The listed applicant is Martech Medical Products, Inc.. The 510(k) number is K890473.

When did NEEDLE GUARD(TM) receive FDA 510(k) clearance?

NEEDLE GUARD(TM) received FDA 510(k) clearance on 1989-04-03, under 510(k) number K890473.

Who is the listed applicant for NEEDLE GUARD(TM)?

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

What is the FDA product code for NEEDLE GUARD(TM)?

The FDA product code for NEEDLE GUARD(TM) is FMI.

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Other records listing Martech Medical Products, Inc. as applicant

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.

K960519MARTECH ENDOSCOPIC INJECTION NEEDLEK931924MARKSMAN ARTERIAL BLOOD GAS SYRINGEK922438PRO2 OXYGEN ANALYZERK926007ACCESSORY TO PISTON SYRINGEK914778NEOLINE(TM)K910970MARKSMAN ARTERIAL BLOOD GAS SYRINGE

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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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