LogoFDA 510(k) Search
Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K965136
    Device Name
    UROSURGE UROTHERM FLUID WARMING SYSTEM
    Manufacturer
    PRINCETON REGULATORY ASSOC.
    Date Cleared
    1998-10-16

    (662 days)

    Product Code
    LHC
    Regulation Number
    890.5950
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRINCETON REGULATORY ASSOC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UroSurge UroTherm™ Fluid Warming System is intended to varm sterile irrigating solutions to normothermic temperatures (37°C) for use in medical/surgical procedures. Not for use with blood or blood products.
    Device Description
    UroSurge UroTherm™ Fluid Warning System
    Ask a Question
    K Number
    K972158
    Device Name
    GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
    Manufacturer
    PRINCETON REGULATORY ASSOC.
    Date Cleared
    1998-02-20

    (256 days)

    Product Code
    MEB
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRINCETON REGULATORY ASSOC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GO Medical Patient Controlled Analgesia Devices™, if properly used, are intended to provide a safe and effective means of delivering various analgesic medications to in-patients and out-patients, on both an acute and/or chronic basis. This can be performed through intravenous (IV) and Epidural routes of administration.
    Device Description
    Not Found
    Ask a Question
    K Number
    K973504
    Device Name
    UROSURGE UROSTENT
    Manufacturer
    PRINCETON REGULATORY ASSOC.
    Date Cleared
    1998-01-30

    (136 days)

    Product Code
    FAD
    Regulation Number
    876.4620
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRINCETON REGULATORY ASSOC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UroSurge UroStent™ is intended to be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or open surgical techniques. The duration of the placement of these stents must not remain indwelling more than twenty nine (29) days. This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.
    Device Description
    Not Found
    Ask a Question
    K Number
    K962770
    Device Name
    UROSURGE ACUTRAINER
    Manufacturer
    PRINCETON REGULATORY ASSOC.
    Date Cleared
    1996-08-01

    (16 days)

    Product Code
    KPN
    Regulation Number
    876.2040
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRINCETON REGULATORY ASSOC.

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

    Page 1 of 1