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510(k) Data Aggregation

    K Number
    K092421
    Device Name
    ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC
    Manufacturer
    GIMMI GMBH
    Date Cleared
    2010-02-12

    (189 days)

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

    GIMMI GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AlphaScope Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. AlphaScope Hysteroscope is used with Hysteroscope Sheaths to provide access to the uterine cavity during diagnostic and operative hysteroscopic procedures.
    Device Description
    AlphaScope Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. AlphaScope Hysteroscope is used with Hysteroscope Sheaths to provide access to the uterine cavity during diagnostic and operative hysteroscopic procedures. The use of AlphaScope Hysteroscope is restricted for the use of endoscopic surgeons and qualified assistants. AlphaScope Hysteroscopes are re-useable, they can be sterilized by 134 C Degrees Steam Autoclave.
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    K Number
    K093125
    Device Name
    ALPHAXENON LIGHT 180 W AND 300 W
    Manufacturer
    GIMMI GMBH
    Date Cleared
    2010-01-27

    (117 days)

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

    GIMMI GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AlphaXenon Light 300W and 180W light source is used with an endoscope to provide illumination during endoscopic procedures.
    Device Description
    AlphaXenon Light is a light generating device that when used with in conjunction with endoscopes to illuminate surgical site during Endoscopic procedures.
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    K Number
    K081640
    Device Name
    GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
    Manufacturer
    GIMMI GMBH
    Date Cleared
    2009-05-06

    (329 days)

    Product Code
    HCH
    Regulation Number
    882.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    GIMMI GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Permanent GIMMI Aneurysm Clips (Yasargil) and vessel clips are intended for Permanent occlusion of blood vessels and cerebral aneurysms. Likewise, temporary permianent occlusion of blood vessel clips are intended for temporary occlusion Gilvilli Aneurysin Olips (Tabargi) and cerebral aneurysms. They are also intended to be applied exclusively with the corresponding Clip Appliers.
    Device Description
    GIMMI Aneurysm Clips and their Clip Applying Forceps are used for the occlusion of aneurysms. "Mini" and "Standard" Clips can only be applied with the according Applying forceps; these forceps are labelled with "Mini" or "Standard". Clips are available in different sizes and shapes, to have the right size and shape due to the size and shape of the aneurysm.
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    K Number
    K012869
    Device Name
    GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25
    Manufacturer
    GIMMI GMBH
    Date Cleared
    2002-03-11

    (196 days)

    Product Code
    HIH, HDC, HET, HHO, KNA
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    GIMMI GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GIMMI ALPHA® Hysteroscopes and Accessories are intended to be used by qualified physicians to provide access, illumination and visualization of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. These generic devices are used to perform diagnostic and surgical procedures.
    Device Description
    GIMMI ALPHA Hysteroscopes are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of 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. Laparoscopic and obstetric-gynecologic accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. Some specialized instruments, such as the gynecologic fibroid screw and uterine tenaculum are one-piece. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing).
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    K Number
    K012660
    Device Name
    GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
    Manufacturer
    GIMMI GMBH
    Date Cleared
    2001-12-20

    (129 days)

    Product Code
    FET, EZO, FAJ, FAS, FBK, FBM, FCL, FDC, FDE, FED, FGC, FHA, FJL, GBZ, GCJ, GCT, GEI, KNS, KOA, KOD, KOE, KQT, LQR
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    GIMMI GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GIMMI ALPHA® Gastro-Urology and Laparoscopic Endoscopes, Endoscopic Accessories and GIMMI devices for minimally invasive gastrointestinal (GI), genitourinary (GU), and laparoscopic diagnostic and/or therapeutic indications are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic and minimally invasive procedures.
    Device Description
    GIMMI ALPHA Endoscopes are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of 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. Laparoscopic and urological-gastroenterologic and related accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. Needle holders and other Class I devices included in the endoscopic catalogs may be onepiece. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing). Minimally Invasive Gl and GU Devices are design specific for short term use in diagnostic and/or therapeutic procedures
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    K Number
    K013731
    Device Name
    GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03
    Manufacturer
    GIMMI GMBH
    Date Cleared
    2001-11-27

    (18 days)

    Product Code
    EOQ, EOB
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    GIMMI GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GIMMI ALPHA Sinuscopes and Bronchoscopes are intended for use by qualified physicians to perform endoscopic diagnostic and therapeutic surgical procedures of the sinus and larynx/tracheobronchial tree respectively. GIMMI ALPHA® Bronchoscopes are intended to provide qualified physicians with a means for performing endoscopic diagnostic and therapeutic surgical procedures of the larynx and tracheobronchial tree. GIMMI ALPHA® Sinuscopes are intended to provide qualified physicians with a means for performing endoscopic diagnostic and therapeutic sinus surgical procedures.
    Device Description
    GIMMI ALPHA Sinuscopes and Bronchoscopes are reusable, hand-held instruments designed for performing diagnostic and therapeutic sinus and bronchial procedures. The devices have the same operating principles and intended uses as many of the competitive sinuscopes and bronchoscopes already in commercial distribution. The devices are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of 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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