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510(k) Data Aggregation

    K Number
    K121261
    Device Name
    ASAP MUITISCOPE
    Manufacturer
    ASAP ENDOSCOPIC PRODUCTS GMBH
    Date Cleared
    2013-01-08

    (257 days)

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

    ASAP ENDOSCOPIC PRODUCTS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The asap multiscope is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, discectomy, and foraminotomy.
    Device Description
    The asap multiscope is a rigid or semiflex-type multi-channel endoscope provided with a rod lens system to transmit light and images, a working channel and one or two irrigation channel(s) and stopcocks. The body consists of an outer and an inner tube of surgical steel. The light-carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod lens system, the working channel and the irrigation/suction channel(s). The eyepiece and light post are adaptable to standard endoscopic cameras and light systems. The endoscope is intended for use with standard working sheaths (cannulas) for minimally invasive access. Accessories include working sheaths, spinal needles, guide wire, dilators, trephine, hammers, trocars, forceps, and rongeurs, as well as cleaning brushes, a rubber sealing cap, spare O-rings, and a protection sheath.
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    K Number
    K032822
    Device Name
    ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0
    Manufacturer
    ASAP ENDOSCOPIC PRODUCTS GMBH
    Date Cleared
    2004-01-08

    (120 days)

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

    ASAP ENDOSCOPIC PRODUCTS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The asap ENT endoscope is intended to provide the physician with a means for direct viewing of the nasal cavity and nasal pharynx by providing illumination and visualization of these regions during various diagnostic and therapeutic procedures. The asap ENT endoscope is reusable.
    Device Description
    The asap ENT endoscope is of the rigid type with a new generation of compact objectives and a newly developed rod-lens system. The basic design of the asap ENT endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
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    K Number
    K031974
    Device Name
    ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0
    Manufacturer
    ASAP ENDOSCOPIC PRODUCTS GMBH
    Date Cleared
    2003-09-29

    (95 days)

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

    ASAP ENDOSCOPIC PRODUCTS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hysteroscope: Provides illumination and visualization of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. Gynecologic Laparoscope: Used to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.
    Device Description
    The asap hysteroscope and gynecologic laparoscope (herinafter: asap endoscope) is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system. The basic design of the asap endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
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    K Number
    K031972
    Device Name
    ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,
    Manufacturer
    ASAP ENDOSCOPIC PRODUCTS GMBH
    Date Cleared
    2003-09-15

    (81 days)

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

    ASAP ENDOSCOPIC PRODUCTS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The asap arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrlst (carpal tunnel syndrome), temporal-mandibular joint, ankle and elbow. The asap arthroscope is reusable and has to be sterilized prior to each procedure by the user. The intended use for the asap arthroscope is according to relevant medical indication by trained physicians only.
    Device Description
    The asap arthroscope is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system. The basic design of the asap arthroscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light quide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
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    K Number
    K031141
    Device Name
    ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE
    Manufacturer
    ASAP ENDOSCOPIC PRODUCTS GMBH
    Date Cleared
    2003-06-30

    (81 days)

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

    ASAP ENDOSCOPIC PRODUCTS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Like the predicate devices, the asap endoscope is used to visualize the body cavities, hollow organs and canals during diagnostic and, in conjunction with additional instruments, therapeutic procedures.
    Device Description
    The asap endoscope is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system. The basic design of the asap endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
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