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FDA 510(k)

PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION

K-Number: K003827 · 2001-01-08

ApplicantBio-Plexus, Inc.
Decision Date2001-01-08
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION 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 2001-01-08 under 510(k) number K003827. 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 PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION?

PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION is a medical device that received FDA 510(k) clearance on 2001-01-08. The listed applicant is Bio-Plexus, Inc.. The 510(k) number is K003827.

When did PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION receive FDA 510(k) clearance?

PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION received FDA 510(k) clearance on 2001-01-08, under 510(k) number K003827.

Who is the listed applicant for PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION?

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 PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION?

The FDA product code for PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION is FMI.

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Other records listing Bio-Plexus, 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.

K992091PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750K963748BIO-PLEXUS DROP-IT NEEDLE HOLDERK960933BIO-PLEXUS NEEDLE DISPOSAL CONTAINERK961251PUNCTUR-GUARD WINGED SETK895024PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE

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

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

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