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510(k) Data Aggregation

    K Number
    K023261
    Device Name
    ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244
    Manufacturer
    TAUT, INC.
    Date Cleared
    2002-12-13

    (74 days)

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

    TAUT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ADAPI™ Balloon Open Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.
    Device Description
    Not Found
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    K Number
    K021731
    Device Name
    ADAPT OPEN ACCESS PORT, MODEL 41233
    Manufacturer
    TAUT, INC.
    Date Cleared
    2002-08-08

    (76 days)

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

    TAUT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ADAPt™ Open Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.
    Device Description
    ADAPt™ Open Access Port, Model 41233
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    K Number
    K011018
    Device Name
    TAUT BALLOON CATHETER, MODEL 50640
    Manufacturer
    TAUT, INC.
    Date Cleared
    2001-06-22

    (79 days)

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

    TAUT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003703
    Device Name
    TAUT-INSUFFLATION NEEDLE
    Manufacturer
    TAUT, INC.
    Date Cleared
    2001-02-22

    (83 days)

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

    TAUT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010007
    Device Name
    ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP
    Manufacturer
    TAUT, INC.
    Date Cleared
    2001-02-22

    (51 days)

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

    TAUT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K992904
    Device Name
    MINI-PORT
    Manufacturer
    TAUT, INC.
    Date Cleared
    1999-10-05

    (36 days)

    Product Code
    GBW, HIF
    Regulation Number
    878.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAUT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as an abdominal access port during a laparoscopic procedure and the 1-way stopcock for attaching insufflation tubing to maintain pneumoperitoneal pressure.
    Device Description
    Not Found
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    K Number
    K992907
    Device Name
    INTRADUCER
    Manufacturer
    TAUT, INC.
    Date Cleared
    1999-10-05

    (36 days)

    Product Code
    GBW
    Regulation Number
    878.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAUT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide an access port into the peritoneal cavity.
    Device Description
    Not Found
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    K Number
    K972112
    Device Name
    INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450
    Manufacturer
    TAUT, INC.
    Date Cleared
    1997-12-01

    (179 days)

    Product Code
    GBW
    Regulation Number
    878.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAUT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE DEVICE IS INTENDED FOR USE AS AN ABDOMINAL ACCESS PORT DURING LAPARASCOPIC PROCEDURE AND THE VALVE FOR ATTACHING INSUFFLATION TUBING TO MAINTAIN PNEUMOPERITONEAL PRESSURE.
    Device Description
    Not Found
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    K Number
    K962003
    Device Name
    TUAT SPLATTER CONTROL SHIELD SCS-300
    Manufacturer
    TAUT, INC.
    Date Cleared
    1996-07-18

    (57 days)

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

    TAUT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960883
    Device Name
    INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8
    Manufacturer
    TAUT, INC.
    Date Cleared
    1996-03-20

    (15 days)

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

    TAUT, INC.

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

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