FDA 510(k)

WINGED NON-CORING NEEDLE SET

K-Number: K884212 · 1988-10-17

Decision Date1988-10-17

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

WINGED NON-CORING NEEDLE SET is the device name listed in this FDA 510(k) record. The listed applicant is Marquette Medical, Inc.. It received FDA 510(k) clearance on 1988-10-17 under 510(k) number K884212. 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 WINGED NON-CORING NEEDLE SET?

WINGED NON-CORING NEEDLE SET is a medical device that received FDA 510(k) clearance on 1988-10-17. The listed applicant is Marquette Medical, Inc.. The 510(k) number is K884212.

When did WINGED NON-CORING NEEDLE SET receive FDA 510(k) clearance?

WINGED NON-CORING NEEDLE SET received FDA 510(k) clearance on 1988-10-17, under 510(k) number K884212.

Who is the listed applicant for WINGED NON-CORING NEEDLE SET?

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

What is the FDA product code for WINGED NON-CORING NEEDLE SET?

The FDA product code for WINGED NON-CORING NEEDLE SET is FMI.

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Other records listing Marquette Medical, Inc. as applicant

K021471MARQUETTE HUBER TRAP SAFETY INFUSION SET K953008INFANT FEEDING TUBE K952976PLASTIC BLUNT CANNULA K920537SUBCUTANEOUS INFUSION SET K9052184 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMP K9052194' LOW VOLUME IV EXTENSION SET

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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.