LogoFDA 510(k) Search
Search Filters

Search Results

Found 8 results

510(k) Data Aggregation

    K Number
    K031014
    Device Name
    HI-FLO THERME PNEU 45, WISAP #7083, 7083V
    Manufacturer
    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
    Date Cleared
    2003-06-27

    (88 days)

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

    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WISAP Multi Hi-Flo Therme Pneu 45 may only be used for building up a pneumoperitoneum with CO2Gas for diagnostic or operative Pelviscopy/Laparoscopy. The Flow-Therme integrated in the appliance preheats the insufflation gas to body temperature.
    Device Description
    Not Found
    Ask a Question
    K Number
    K011510
    Device Name
    MULTI HI-FLO PNEU, WISAP #7080
    Manufacturer
    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
    Date Cleared
    2002-04-02

    (321 days)

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

    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K992481
    Device Name
    CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
    Manufacturer
    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
    Date Cleared
    2000-03-17

    (235 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WISAP CO2-OP-Pneu Computer 7050C/7050CF/7050CM/7050CMF may only be used for building up a pneumoperitoneum with CO2-Gas for diagnostic or operative Pelviscopy/Laparoscopy.
    Device Description
    Not Found
    Ask a Question
    K Number
    K992513
    Device Name
    THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
    Manufacturer
    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
    Date Cleared
    2000-03-17

    (235 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This decice is restricted to use by authorized expert personnel / physicians! The WISAP THERME-PNEU Computer 7070C/7070CM/7070CM/7070CMF may only be used for building up a pneumoperitoneum with CO .- Gas for diagnostic or operative Pelviscopy/Laparoscopy. The Flow-Therme integrated in the appliance preheats the insufflation gas to body temperature.
    Device Description
    Not Found
    Ask a Question
    K Number
    K990662
    Device Name
    DISPOSABLE HEATING TUBING SET #7642HSES
    Manufacturer
    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
    Date Cleared
    1999-09-24

    (207 days)

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

    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is restricted to use by authorized expert personnel/physicians. The WISAP Disposable Heating Tube 7642HSE is a laparoscopic accessory to be used in connection with the WISAP (02 insufflator. This system serves for building up a pneumoperitoneum during diagnostic-operative Pelviscopy/Laparoscopy. The insufflation gas is preheated to body temperature by the disposable tubing.
    Device Description
    Laparoscopic Insufflator: Disposable Heating Tubing Set #7642 HSES
    Ask a Question
    K Number
    K982515
    Device Name
    POWER-DRIVE, WISAP MODEL #7688PD/7688PD1
    Manufacturer
    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
    Date Cleared
    1999-01-19

    (183 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is restricted to use by authorized expert personnel/physicians. The WISAP POWER-DRIVE is a laparoscopic accessory to be used in connection with the S*E*M*M*-Set. It allows cutting of tissue cylinders out of myoma and uterion. It allows cutting of Cissue cyrinkers out intermittent manual rocation. rotation of the motor drive or additional interest manual rocation. The POWER-DRIVE may only be used for horizontal morcellation.
    Device Description
    The WISAP POWER-DRIVE is a laparoscopic accessory to be used in connection with the S*E*M*M*-Set. It allows cutting of tissue cylinders out of myoma and uterion. It allows cutting of Cissue cyrinkers out intermittent manual rocation. rotation of the motor drive or additional interest manual rocation. The POWER-DRIVE may only be used for horizontal morcellation.
    Ask a Question
    K Number
    K982518
    Device Name
    AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608
    Manufacturer
    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
    Date Cleared
    1999-01-14

    (178 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is restricted to use by authorized expert personnel/physicians. The WISAP Aqua-Purator Biotherm 1608 is solely destined for operative therapeutical Pelviscopy/Laparoscopy for lavage of the abdominal cavity with physiological saline solution coming from plastic bags up to 5 1 volume. The irrigation pressure can be preselected; the preheated liquid in the bag is kept at body temperature.
    Device Description
    Aqua-Purator Biotherme 1608
    Ask a Question
    K Number
    K960640
    Device Name
    S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)
    Manufacturer
    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
    Date Cleared
    1997-02-14

    (368 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH

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

    Page 1 of 1