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510(k) Data Aggregation

    K Number
    K992499
    Device Name
    GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE
    Manufacturer
    GALLINI U.S., LLC.
    Date Cleared
    1999-08-12

    (17 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    GALLINI U.S., LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gallini BIOSYSTEM Needle is used for bone biopsy and aspiration procedures.
    Device Description
    Not Found
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    K Number
    K990645
    Device Name
    GALLINI ATRA-CUT NEEDLE
    Manufacturer
    GALLINI U.S., LLC.
    Date Cleared
    1999-05-19

    (82 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    GALLINI U.S., LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gallini Atra-Cut Needle is used for fine bone biopsy and aspiration procedures.
    Device Description
    Not Found
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    K Number
    K990716
    Device Name
    GALLINI BYCUT NEEDLE
    Manufacturer
    GALLINI U.S., LLC.
    Date Cleared
    1999-05-17

    (74 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    GALLINI U.S., LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gallini Bycut Needle is used for bone biopsy.
    Device Description
    Not Found
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    K Number
    K981301
    Device Name
    SPEED-CUT AUTOMATIC BIOPSY SYSTEM
    Manufacturer
    GALLINI U.S., LLC.
    Date Cleared
    1998-07-08

    (90 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    GALLINI U.S., LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Speed-Cut is an automatic disposable biopsy instrument designed to take core samples from a variety of soft tissues including the liver, prostate and kidney.
    Device Description
    The Speed-Cut is an automatic disposable biopsy instrument designed to take core samples from a variety of soft tissues including the liver, prostate and kidney.
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    K Number
    K980676
    Device Name
    SPIGAL NEEDLE
    Manufacturer
    GALLINI U.S., LLC.
    Date Cleared
    1998-05-21

    (90 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    GALLINI U.S., LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is to be used for spinal biopsies.
    Device Description
    Not Found
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    K Number
    K980479
    Device Name
    QUICK-CUT AUTOMATIC BIOPSY SYSTEM
    Manufacturer
    GALLINI U.S., LLC.
    Date Cleared
    1998-05-06

    (89 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    GALLINI U.S., LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is to be used for soft tissue biopsy.
    Device Description
    Quick-Cut® Automatic Biopsy System
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    K Number
    K980248
    Device Name
    ACRI R NEEDLE
    Manufacturer
    GALLINI U.S., LLC.
    Date Cleared
    1998-02-18

    (26 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    GALLINI U.S., LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is to be used for bone marrow aspiration biopsy from the sternum or iliac crest.
    Device Description
    ACRI-R Needle
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    K Number
    K974440
    Device Name
    IBI
    Manufacturer
    GALLINI U.S., LLC.
    Date Cleared
    1998-01-30

    (66 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    GALLINI U.S., LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is to be used for taking histological and cytological biopsies of soft tissue.
    Device Description
    IBI® Needle
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    K Number
    K973152
    Device Name
    GALLINI ABS DEVICE
    Manufacturer
    GALLINI U.S., LLC.
    Date Cleared
    1998-01-09

    (140 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    GALLINI U.S., LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The instrument is designed to be used for high-speed histological biopsy.
    Device Description
    ABS® Device
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    K Number
    K972266
    Device Name
    GALLINI COAXIAL INTRODUCER
    Manufacturer
    GALLINI U.S., LLC.
    Date Cleared
    1997-07-29

    (42 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    GALLINI U.S., LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The instrument is designed to be used to provide access to lesions to be biopsied.
    Device Description
    Coaxial Introducer
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