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510(k) Data Aggregation

    K Number
    K052802
    Device Name
    MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    2005-11-01

    (29 days)

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

    MANAN MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bio-Cut Soft Tissue Biopsy Needle is intended for harvesting soft tissue biopsy specimens.
    Device Description
    The biopsy instrument is a sterile disposable device which features a stainless steel cannula with an echogenic tip, and a stainless steel stylet which is spring loaded and fitted into a plastic handle permitting single handed specimen collection. Sizes are available in 14 - 20 gauge needles. The length of the needles ranges between 9 and 20 cm. The needle is used by advancing the entire device to the site of soft tissue sampling. The needle is advanced with gentle but firm pressure. Once the needle is in position, the sample is taken and the device is removed from the sampling site. The sample can then be expelled from the stylet notch.
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    K Number
    K011209
    Device Name
    MANAN SPRITACRE SPINAL NEEDLES
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    2001-06-26

    (68 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    MANAN MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K983620
    Device Name
    MANAN SPINAL NEEDLES
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    1999-01-08

    (85 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    MANAN MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the spinal administration of anesthetic agents to elicit regional anesthesia.
    Device Description
    Spinal Needle
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    K Number
    K980536
    Device Name
    EPIDURAL NEEDLE
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-07-31

    (170 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    MANAN MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the epidural placement, directly or through a catheter, of anesthetic agents to elicit regional anesthesia.
    Device Description
    Epidural Needle (Touhy, Hustead, Crawford, Weiss)
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    K Number
    K981386
    Device Name
    MANAN BLUNT NEEDLE
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-06-29

    (74 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    MANAN MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For simplifying insertion of a guide-wire and/or catheter through various ports(such as a Touhy-Borst) used in intravascular administration sets.
    Device Description
    Blunt Needle
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    K Number
    K980211
    Device Name
    MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-02-06

    (16 days)

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

    MANAN MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues through a combination of cutting and/or aspirating. The breast localization needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain breast lesion tissue.
    Device Description
    The biopsy needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues through a combination of cutting and/or aspirating. The breast localization need in MRI, Fluoroscopic, CT and Mammographic procedures to obtain breast lesion tissue.
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    K Number
    K974446
    Device Name
    MANAN AUTOMATIC CUTTING NEEDLE
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-01-08

    (44 days)

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

    MANAN MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Needle can be used for obtaining core and/or aspiration biopsies of various tissues (Prostate, lung, kidney, liver, spleen, thyroid, adrenals, abdominal soft tissue masses, breast). For Breast Biopsy this product is for diagnosis only-not for therapeutic use.
    Device Description
    Automatic Cutting Needle
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    K Number
    K962977
    Device Name
    MRI COMPATIBLE BIOPSY NEEDLES
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-10-09

    (435 days)

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

    MANAN MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Needles can be used in MRI, Flouroscopic, CT and Mammographic procedures for obtaining biopsies of various tissues.
    Device Description
    MRI Chiba Needle, MRI Spinal Needle, MRI Automatic Cutting Needle, MRI General Purpose Introducer Needle, MRI Techna-Cut Biopsy Needle, MRI Super-Core Biopsy Needle, MRI Breast Localization Needle, and MRI Simon Breast Localization Needle
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    K Number
    K963767
    Device Name
    MANAN V.S. ACCESS NEEDLE/SET
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-05-16

    (239 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    MANAN MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961986
    Device Name
    MANAN D BAG
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-03-13

    (296 days)

    Product Code
    EXF
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    MANAN MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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