LogoFDA 510(k) Search
Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    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?
    Product Code :

    GBW

    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
    Ask a Question
    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?
    Product Code :

    GBW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide an access port into the peritoneal cavity.
    Device Description
    Not Found
    Ask a Question
    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?
    Product Code :

    GBW

    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
    Ask a Question
    K Number
    K961194
    Device Name
    ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN
    Manufacturer
    SIL-MED CORP.
    Date Cleared
    1996-08-08

    (134 days)

    Product Code
    GBW
    Regulation Number
    878.4200
    Why did this record match?
    Product Code :

    GBW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Catheter for drainage of blood and fluid from mediastinum after chest surgery and/or trauma; for use with suction apparatus
    Device Description
    Silicone perforated tubing, flattened profile, blue radiopaque stripe; surface treated to reduce friction and Antimicrobial; perforations ("eyes") on both flattened surfaces of tubing; external end has cutaway adapter; imprinted with drain size
    Ask a Question
    K Number
    K960426
    Device Name
    MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Date Cleared
    1996-03-21

    (52 days)

    Product Code
    GBW
    Regulation Number
    878.4200
    Why did this record match?
    Product Code :

    GBW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K942709
    Device Name
    MEDIASTINAL SILICONE DRAINS
    Manufacturer
    SIL-MED CORP.
    Date Cleared
    1996-01-04

    (575 days)

    Product Code
    GBW
    Regulation Number
    878.4200
    Why did this record match?
    Product Code :

    GBW

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

    Page 1 of 1