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510(k) Data Aggregation

    K Number
    K973958
    Device Name
    GENERAL PURPOSE ATL NEEDLE GUIDE KIT
    Manufacturer
    PROTEK MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-01-22

    (98 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROTEK MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The General Purpose ATL Needle Guide Kit consists of accessories for the Model ATL C3 Scanhead which are used for guiding a needle or catheter during a diagnostic ultrasound procedure in order to perform a biopsy or precise needle placement. The subject device is to be used only for those indications which have been FDA-cleared for the Model ATL C3 Scanhead (consult transducer manual).
    Device Description
    General Purpose ATL Needle Guide Kit for use with ATL Ultrasound Transducers
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    K Number
    K973622
    Device Name
    TRANSDUCER POSITIONER
    Manufacturer
    PROTEK MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-11-26

    (64 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROTEK MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An ultrasound accessory device used for positioning and guiding an ultrasound transducer probe during volume measurements of the prostate. Used in conjunction with a needle guide grid or radiation seed needle placement for the deposit of seeds.
    Device Description
    Transducer Positioner
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    K Number
    K970889
    Device Name
    ULTRASOUND TRANSDUCER DRAPE
    Manufacturer
    PROTEK MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-10-20

    (223 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROTEK MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A polyethylene cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as is placed on the instrument prior to coming in contact with the human bodies internal and external services. The following is an abbreviated list of known uses: 1. General Purpose: Ultrasound scanning 2. Cord cover for an extended sterile field on ultrasound transducer cords. 3. Rectal and vaginal scanning. 4. Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contamination. Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contaminations.
    Device Description
    A variety of kits, ranging in sizes, containing a disposable, single use, sterile instrument cover/drape, gel, bands and tape. The sterile bag is placed over a non-sterile ultrasound transducer probe during a sterile procedure, acting as a barrier between the patient and the ultrasound probe. Each kit contains one cover/drape, ranging in sizes from 2"x24" to 5"x100", made from extruded Polyethylene film, with a thickness of .001inches-.003inches, Conductivity Gel, Elastic Bands, and Plastic Medical Tape.
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    K Number
    K970893
    Device Name
    ULTRASOUND TRANSDUCER DRAPE
    Manufacturer
    PROTEK MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-10-20

    (223 days)

    Product Code
    FYA, KKX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROTEK MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A polyurethane cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as it is placed on the instrument prior to coming in contact with the human bodies internal and external services. The following is an abbreviated list of known uses; 1. General Purpose: Ultrasound scanning. 2. Cord cover for an extended sterile field on ultrasound transducer cords. 3. Rectal and vaginal scanning. 4. Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contamination.
    Device Description
    A variety of kits, ranging in sizes, containing a disposable, single use, sterile instrument cover/drape, gel, bands and tape. The sterile bag is placed over a non-sterile ultrasound transducer probe during a sterile procedure, acting as a barrier between the patient and the ultrasound probe. Each kit contains one cover/drape, ranging in sizes from 2"x24" to 5"x100", made from extruded Polyurethane film, with a thickness of .001-. 003 inches, Conductivity Gel, Elastic Bands, and Plastic Medical Tape.
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    K Number
    K973362
    Device Name
    NEEDLE GUIDE/GRID
    Manufacturer
    PROTEK MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-10-01

    (23 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROTEK MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A needle guidance device for prostate biopsies or radiation seed placement/needles used as an accessory with an ultrasound transducer and system.
    Device Description
    Needle Guide/Grid
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    K Number
    K970885
    Device Name
    ULTRASOUND SYSTEMS DRAPE
    Manufacturer
    PROTEK MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-09-22

    (195 days)

    Product Code
    MMP
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROTEK MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultrasound System Drape Kit - Polyethylene Drapes for covering Monitors, Keyboards, Floorpedals, and Equipment Arms
    Device Description
    Not Found
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    K Number
    K970891
    Device Name
    DRAPE, SURGICAL-LATEX
    Manufacturer
    PROTEK MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-08-22

    (164 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROTEK MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A surgical drape and drape accessories used as a protective covering between an instrument and the patient to isolate a site of surgical incision from microbial and other contaminants
    Device Description
    A sterile bag to contain a non-sterile ultrasound transducer probe during a sterile procedure. A disposable, single use, sterile instrument cover/drape to protect the patients from cross contamination from bacteria's of a non-sterile ultrasound transducer probe. A sterile barrier between patient and ultrasound transducer probe.
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    K Number
    K971722
    Device Name
    TRANS VAGINAL NEEDLE GUIDE
    Manufacturer
    PROTEK MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-07-10

    (62 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROTEK MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Accessory-Needle Guides used for Vaginal Ultrasound Transducers for performing Vaginal Biopsies.
    Device Description
    A tube, a cannula that is an accessory that snaps or rests(depending on configuration) onto an ultrasound transducer(884.2960) A disposable, single use, sterile tube that helps direct a needle, biopsy or catheter to a target working in conjunction with an ultrasound transducer and system A stainless steel cannula or plastic tube with a small clip or bracket for locating and securing. Dimensions and designs vary and are specified with the original equipment manufacturer of ultrasound systems and transducers
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    K Number
    K971115
    Device Name
    GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE
    Manufacturer
    PROTEK MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-06-13

    (78 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROTEK MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used to assist doctors when performing a prostate biopsy. Used to guide a needle, biopsy or catheter into the prostate gland. Used as an accessory in conjunction with an ultrasound transducer (892.1570). Used to improve needle placement vs. guiding needle with the finger. Needle Guides for Rectal Ultrasound Transducers used in prostate biopsies.
    Device Description
    A tube, a cannula that is an accessory that snaps or rests (depending on configuration) onto an ultrasound transducer (892.1570). A disposable, single use, sterile tube that helps direct a needle, biopsy or catheter to a target working in conjunction with an ultrasound transducer and system. A stainless steel cannula or plastic tube with a small clip or bracket for locating and securing. Dimensions and designs vary and are specified with the original equipment manufacturer of ultrasound systems and transducers.
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