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510(k) Data Aggregation

    K Number
    K002269
    Device Name
    ELECTROSURGICAL PROBES AND DEVICES-GELTX
    Manufacturer
    XIMED/PROSURE/INJECTX
    Date Cleared
    2001-01-04

    (162 days)

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

    XIMED/PROSURE/INJECTX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994151
    Device Name
    PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
    Manufacturer
    XIMED/PROSURE/INJECTX
    Date Cleared
    2000-03-01

    (83 days)

    Product Code
    GAA
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    XIMED/PROSURE/INJECTX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PercuTx - Injection /Aspiration Needle device is indicated for use as an accessory for currently marketed endoscopes to provide for delivery of injectable materials into tissues during endoscopic procedures. As with currently marketed endoscopic injection needles, the PercuTx Endoscopic Injection needle device may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials which have received approval for use by the FDA. The type of material to be injected will be dependent on the nature of the endoscopic procedure, but such materials may include for example: delivery of collagen during cystoscopic procedures; delivery of sclerosing agents during esophagoscopic, and gastroscopic procedures; delivery of local anesthetics during cystoscopic or laryngoscopic procedures; or delivery of saline or contrast media during colonoscopic.
    Device Description
    PercuTxTM Injection/Aspiration Needle Probes with Control Handpiece
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    K Number
    K983200
    Device Name
    INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
    Manufacturer
    XIMED/PROSURE/INJECTX
    Date Cleared
    1998-12-11

    (88 days)

    Product Code
    GAA
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    XIMED/PROSURE/INJECTX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Injection/ Aspiration probes and devices are to be used independently or with commercially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes, and suction/irrigation systems. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, and other endoscopic and open surgical procedures designed for injection and aspiration of fluids and solutions in the tissue or body. This device is not intended for injection of drugs.
    Device Description
    Injection/Aspiration Needles Probes/Devices
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    K Number
    K983765
    Device Name
    INJECTION NEEDLE PROBE/DEVICE-TUNIS
    Manufacturer
    XIMED/PROSURE/INJECTX
    Date Cleared
    1998-12-11

    (46 days)

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

    XIMED/PROSURE/INJECTX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TUNIS™ probes and devices are to be used independently or with commercially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes for transurethral injection procedures. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, and other endoscopic & open surgical procedures designed for interstitial injection/aspiration of biomaterials, fluids and solutions in the urinary bladder and lower urinary tract.
    Device Description
    TUNIS™ - Transurethral Injection System Probe/Device
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    K Number
    K981256
    Device Name
    ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE
    Manufacturer
    XIMED/PROSURE/INJECTX
    Date Cleared
    1998-05-12

    (40 days)

    Product Code
    FAS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    XIMED/PROSURE/INJECTX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    electrosurgical probes and devices are to be used with The commercially available R.F. generators, endoscopes including laparoscopes, hysteroscopes, resectoscopes, cystoscopes and suction/irrigation systems. These devices can be used for lappeoscopic. hysteroscopic, cystoscopic, resectoscopic and other endoscopic and open surgical procedures including TURP, BPH, prostate surgery, and other soft tissue removal using cutting/coagulation/ablation mode of R.F. energy.
    Device Description
    Isolated Electrosurgical Probes & Devices-Salinetrode™M (cutting loops, roller balls, roller bars/barrels, and needles/blades)
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    K Number
    K974484
    Device Name
    ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE
    Manufacturer
    XIMED/PROSURE/INJECTX
    Date Cleared
    1998-02-10

    (76 days)

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

    XIMED/PROSURE/INJECTX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The electrosurgical probes and devices are to be used with commercially availbale R.F. Generators, endoscopes, and suction/irrigation sytems. These devices can be used for laparoscopic, hysteroscopic, endoscopic and open surgical procedures designed for soft tissue removal using coagulation/ablation/vaporization mode of R.F. energy.
    Device Description
    Isolated Electrosurgical Probe/Device-Salinetrode
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    K Number
    K974637
    Device Name
    ELECTRODES/PROBES/DEVICES
    Manufacturer
    XIMED/PROSURE/INJECTX
    Date Cleared
    1998-01-07

    (26 days)

    Product Code
    FAS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    XIMED/PROSURE/INJECTX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The electrosurgical probes and devices are to be used with commercially available R.F. generators, endoscopes including hysteroscopes, resectoscopes, cystoscopes and laparoscopes, suction/irrigation systems. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, resectoscopic and other endoscopic and open surgical procedures including TURP, BPH, prostate surgery, and other soft tissue removal using cutting/coagulation/ablation mode of R.F. energy.
    Device Description
    Electrodes/Probes/Devices
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    K Number
    K962593
    Device Name
    ELECTROSURGICAL PROBES & DEVICES
    Manufacturer
    XIMED/PROSURE/INJECTX
    Date Cleared
    1996-11-12

    (133 days)

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

    XIMED/PROSURE/INJECTX

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

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