FDA 510(k)

BIO-PLEXUS DROP-IT NEEDLE HOLDER

K-Number: K963748 · 1997-06-06

Decision Date1997-06-06

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BIO-PLEXUS DROP-IT NEEDLE HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Plexus, Inc.. It received FDA 510(k) clearance on 1997-06-06 under 510(k) number K963748. 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 BIO-PLEXUS DROP-IT NEEDLE HOLDER?

BIO-PLEXUS DROP-IT NEEDLE HOLDER is a medical device that received FDA 510(k) clearance on 1997-06-06. The listed applicant is Bio-Plexus, Inc.. The 510(k) number is K963748.

When did BIO-PLEXUS DROP-IT NEEDLE HOLDER receive FDA 510(k) clearance?

BIO-PLEXUS DROP-IT NEEDLE HOLDER received FDA 510(k) clearance on 1997-06-06, under 510(k) number K963748.

Who is the listed applicant for BIO-PLEXUS DROP-IT NEEDLE HOLDER?

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

What is the FDA product code for BIO-PLEXUS DROP-IT NEEDLE HOLDER?

The FDA product code for BIO-PLEXUS DROP-IT NEEDLE HOLDER is FMI.

Related Clinical Trials

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Other records listing Bio-Plexus, Inc. as applicant

K003827PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION K992091PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750 K960933BIO-PLEXUS NEEDLE DISPOSAL CONTAINER K961251PUNCTUR-GUARD WINGED SET K895024PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE

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

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