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510(k) Data Aggregation

    K Number
    K170285
    Device Name
    AED Sinuscope
    Manufacturer
    National Advanced Endoscopy Devices, Inc.
    Date Cleared
    2017-08-01

    (183 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    National Advanced Endoscopy Devices, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AED Sinuscope is intended for use in otolaryngology and Head and Neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery.
    Device Description
    The AED Sinuscope is a reusable rod lens sinuscope consisting of an eyepiece lens and a light post connection for fiber optic light cables. A shaft composed of surgical grade stainless steel encloses the glass rod-lens system and a built-in fiber optic light carrier made of glass/acrylic. The light post body is also comprised of surgical stainless steel. The eyepiece is made from Ultem. AED Sinuscopes are manufactured in multiple configurations that differ in insertion tube outer diameter and working length and with respect to optical parameters (direction of view, field of view). The AED Sinuscope is reusable and provided non-sterile. It must be cleaned and sterilized prior to use.
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    K Number
    K141515
    Device Name
    AED HYSTEROSCOPE AND ACCESSORIES
    Manufacturer
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
    Date Cleared
    2015-01-07

    (212 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AED Hysteroscope and Accessories are used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
    Device Description
    The AED Hysteroscope and Accessories is a reusable surgical device that incorporate operative and examination sheaths. The AED Hysteroscope is a reusable rod lens Hysteroscope consisting of an eyepiece lens and a light post connection for fiber optic light cables. A shaft composed of surgical grade stainless steel encloses the glass rod-lens system and a built-in fiber optic light carrier made of glass/acrylic. The light post body is also comprised of surgical stainless steel. The eyepiece is made from Ultem. Examination Sheaths are designed to be used with a hysteroscope alone. An operative sheath is an examination sheath with one or more instrument channels. The operative and examination sheaths are composed of surgical grade stainless steel with the exception of a Fixing Ring (where applicable) which is composed of Nylon. There are two designs for Continuous Flow Sheaths. One design consists of a single sheath with two interior channels (18-2307 and 18-2308) for the inflow and outflow of media to be used with the hysteroscope alone. Alternatively, an inner and outer sheath may be used to perform the same function (18-2304 and 18-2309). The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
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    K Number
    K102663
    Device Name
    AED RESECTOSCOPE
    Manufacturer
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
    Date Cleared
    2010-12-30

    (106 days)

    Product Code
    FJL, FAS, FDC
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for examination, diagnosis and/or therapy in conjunction with endoscopic accessories in the various medical disciplines such as Urology and Gynecology.
    Device Description
    Resectoscopes are used in transuretheral resection of the prostate (TURP) and in transuretheral resection of bladder tumors (TURB). They consist of: - · Endoscope - · Resectoscope sheaths with obturators - · Working Element - · Electrodes The devices are reusable and provided nonsterile. They must be cleaned and sterilized before use. The body contact materials are surgical grade stainless steel which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
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    K Number
    K081553
    Device Name
    AED BIPOLAR FORCEPS, MODEL 13-1646
    Manufacturer
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
    Date Cleared
    2008-09-29

    (118 days)

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

    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AED Bipolar Forceps are reusable devices (bipolar forceps/scissors and electrodes) that facilitate grasping, cutting and manipulation of soft tissue during laparoscopic procedures with the use of high frequency electrical current (bipolar electrocautery). AED Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal ligation/coagulation for sterilization procedures. Do not use these bipolar forceps for these procedures.
    Device Description
    AED Bipolar Forceps consist of • Standard insulated bipolar handles • Outer shaft with insulated tip • Jaw inserts (forceps, scissors) The device is reusable and provided non-sterile. The device must be cleaned and sterilized before use. All forceps are of the same basic design with differences in tip configurations.
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    K Number
    K081503
    Device Name
    AED MONOPOLAR LAP ACCESSORIES
    Manufacturer
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
    Date Cleared
    2008-09-25

    (119 days)

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

    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AED Monopolar Lap Accessories are reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.
    Device Description
    AED Monopolar Lap Accessories consist of Standard insulated monopolar handles Insulated Shafts Class I inserts (forceps, scissors, biopsy cups, needle holders) Electrodes The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
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    K Number
    K993689
    Device Name
    AED CYSTOSCOPE
    Manufacturer
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
    Date Cleared
    1999-12-15

    (44 days)

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

    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used to provide visual information about the interior of the bladder and the urethra for visualization of the interior organ without a surgical procedure. The AED line of rigid Cystoscopes is indicated to provide illumination and visualization in: - Diagnostic cystoscopy procedures.
    Device Description
    AED Cystoscope
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    K Number
    K993688
    Device Name
    AED LAPAROSCOPE
    Manufacturer
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
    Date Cleared
    1999-12-06

    (35 days)

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

    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used to provide visual information about the condition of the interior of the pelvic cavity, and visualization of the interior of the abdominal cavity or areas subject to general or plastic surgery for diagnostic and surgical procedures. This device provides information for diagnosis and/or surgical access with only a small incision. The AED line of rigid Laparoscopes is indicated to provide illumination and visualization in: - Diagnostic and operative laparoscopic procedures.
    Device Description
    AED Laparoscope
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    K Number
    K991656
    Device Name
    AED ARTHROSCOPE
    Manufacturer
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
    Date Cleared
    1999-12-02

    (203 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AED line of rigid Arthroscopes is indicated to provide illumination and visualization in: Diagnostic and operative arthroscope procedures.
    Device Description
    Not Found
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