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FDA 510(k)

PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750

K-Number: K992091 · 1999-09-09

ApplicantBio-Plexus, Inc.
Decision Date1999-09-09
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750 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 1999-09-09 under 510(k) number K992091. 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 REVOLUTION HOLDER, MODEL 4750?

PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750 is a medical device that received FDA 510(k) clearance on 1999-09-09. The listed applicant is Bio-Plexus, Inc.. The 510(k) number is K992091.

When did PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750 receive FDA 510(k) clearance?

PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750 received FDA 510(k) clearance on 1999-09-09, under 510(k) number K992091.

Who is the listed applicant for PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750?

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 REVOLUTION HOLDER, MODEL 4750?

The FDA product code for PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750 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.

K003827PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTIONK963748BIO-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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