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510(k) Data Aggregation

    K Number
    K113080
    Device Name
    TUBALGATOR
    Manufacturer
    MECTRA LABS, INC.
    Date Cleared
    2012-06-29

    (255 days)

    Product Code
    HIN
    Regulation Number
    884.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    MECTRA LABS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K033880
    Device Name
    ELECTRO-LUBE
    Manufacturer
    MECTRA LABS, INC.
    Date Cleared
    2004-03-10

    (86 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MECTRA LABS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electro-Lube is a single patient use device that is intended to be used on electrodes to reduce sticking.
    Device Description
    Electro-Lube is a single patient use device that is intended to be used on electrodes to reduce sticking.
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    K Number
    K021247
    Device Name
    PNEUMOPERITONEUM INSUFFLATION NEEDLE
    Manufacturer
    MECTRA LABS, INC.
    Date Cleared
    2002-11-08

    (203 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    MECTRA LABS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pneumoperitoneum Insufflation Needle is intended for use during Endoscopic procedures, to establish a pneumoperitoneum prior to abdominal endoscopy.
    Device Description
    Not Found
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    K Number
    K993604
    Device Name
    ENDOSCOPIC ANTI FOG DEVICE
    Manufacturer
    MECTRA LABS, INC.
    Date Cleared
    2000-03-03

    (130 days)

    Product Code
    OCT
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MECTRA LABS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endoscopic Anti Fog Device is indicated for use during Endoscopic, laparoscopic, gastroscopic, and arthroscopic procedures, as well as any other procedures which require the use of an endsoscopedevice, to prevent fogging of the endoscope lens.
    Device Description
    Endoscopic Anti Fog Device (Mister Clear)
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    K Number
    K955352
    Device Name
    SUCTION CAUTERY PROBE
    Manufacturer
    MECTRA LABS, INC.
    Date Cleared
    1996-04-05

    (136 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MECTRA LABS, INC.

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

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