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510(k) Data Aggregation

    K Number
    K172661
    Device Name
    Fetzer Medical Gynecological Forceps
    Manufacturer
    Fetzer Medical GmbH & Co. KG
    Date Cleared
    2018-05-08

    (245 days)

    Product Code
    HCZ
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HCZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fetzer Medical Gynecological Forceps are hand-held instruments with dual blades that are indicated for pulling, grasping, holding, or compressing tissue during gynecological procedures.
    Device Description
    This 510(k) covers 31 devices a total of 132 variants representing three general designs (vulsellum, tenaculum, and hysterectomy). These products are reusable manual surgical instruments to be used in gynecological procedures. They are scissor-like, self-retaining devices with ring handles and two blades and made of high-grade stainless steel or titanium. They are available in various sizes with different blade designs at the distal end (e.g., straight or curved). Some of these devices have an additional grasping claw at the distal end. The blades are heavily serrated or may have a profiled longitudinal groove to provide extra grip of the organ. The subject devices vary in the jaw configurations and curvature to meet the surgeon's needs and preferences, based on individual, anatomical variations of the patients. The products are sold nonsterile and can be reused (cleaned and sterilized) according to the instructions for use.
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    K Number
    K134047
    Device Name
    JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Date Cleared
    2014-04-11

    (101 days)

    Product Code
    HCZ
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HCZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Integra® Gynecological Surgical Forceps are hand-held instruments with dual blades that are indicated for pulling, grasping, holding, or compressing tissue during gynecological procedures.
    Device Description
    Integra® Gynecological Surgical Forceps are designed to provide a secure grip on tissue during vaginal and abdominal hysterectomy procedures. These atraumatic instruments are designed to minimize laceration or perforation of the tissue even when required retraction is exerted. Due to differences in anatomy of the site and types of surgical procedures, a variety of configurations and models are offered to provide the surgeon with options to ensure clinical needs are met.
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    K Number
    K092840
    Device Name
    INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL
    Manufacturer
    INSTRUMED INTERNATIONAL, INC.
    Date Cleared
    2009-12-03

    (79 days)

    Product Code
    HCZ
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HCZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INSTRUMED gynaecological forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynaecological examination.
    Device Description
    Instrumed gynaecological forceps are heavy forceps which have special designed jaws to hold securely without slipping during vaginal and abdominal hysterectorny procedures, yet do not lacerate the tissue to which it has been applied to even when it is necessary to exert traction. The Instrumed gynaecological forceps are reusable surgical instruments. To ensure the multi-purpose use of this device, many different models are available. The differences can be as follows: - length and bending of the forceps and jaws . - ring handles with a ratchet closure to adjust the amount of tension applied. - jaw design, option of longitudinal grooves, teeth or cross serrations . - the choice of jaw style depends on the surgeon's preference . The surgeon chooses the gynaecological forceps based on the anatomy of the site and the designs desired are based on the type of the surgical procedure. Instrumed gynaecological forceps are made of the ASTM F 899-07 standardized Stainless Steel. The instruments are offered in non-sterile condition.
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