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    K Number
    K153679
    Device Name
    Stryker Neptune E-SEP Smoke Evacuation Pencil
    Manufacturer
    STRYKER CORPORATION
    Date Cleared
    2016-01-22

    (32 days)

    Product Code
    GEI
    Regulation Number
    878.4400
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neptune E-SEP is an Integrated Smoke Evacuation Pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit (generator) to the operative site for the desired surgical effect.
    Device Description
    The Stryker® Neptune® E-SEPT™ Smoke Evacuation Pencil is a single use monopolar electrosurgical pencil that includes a handpiece with a smoke evacuation function and a range of electrodes (both uncoated and coated). The electrosurgical pencil is compact in size (190 mm long and 17 mm diameter) with 3 m of plastic smoke evacuation tubing and associated electrical cable housed within the tubing. The device is externally powered via an external power generator (supplied by user) connected to a monopolar receptacle using a conventional 3-pin connector. This device remains unchanged from the cleared predicate pencil. The Stryker® Neptune® E-SEPT™ Smoke Evacuation Pencil is available in two activation switch configurations, a rocker style and push-button style, which activates monopolar cut or coagulate functions operated by pressing the respective button. The pencil is connected to smoke evacuation tubing which features a dual connector (8 and 22 mm) to allow the user to connect to a variety of smoke evacuation systems including filtration or central vacuum systems, thus minimizing exposure of personnel to surgical smoke plume. Electrodes are available in Blade, Needle, Ball, T-Bar Loop, U-Bar Loop and Conization geometries and are listed in Table 6-1 below
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    K Number
    K100517
    Device Name
    INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX
    Manufacturer
    INSTRUMED INTERNATIONAL, INC.
    Date Cleared
    2010-04-29

    (65 days)

    Product Code
    HDA
    Regulation Number
    884.4400
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INSTRUMED Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate delivery for the following indications, provided that the fetal head is positioned appropriately in the vagina: · prolonged second stage - · suspicion of immediate or potential fetal compromise - · shortening of the second stage for maternal benefit
    Device Description
    Instrumed obstetrical forceps are instruments designed to aid in the delivery of the fetus. Many different types of forceps have been described and developed. Generally, forceps consist of 2 mirror image metal instruments that are manoeuvred to cradle the fetal head and are articulated, after which traction is applied to effect delivery. Forceps have 4 major components, as follows: - Blades: The blades grasp the fetus. Each blade has a curve to fit around the fetal head. The . blades are oval or elliptical and can be fenestrated (with a hole in the middle) or solid. Many blades are also curved in a plane 90° from the cephalic curve to fit the maternal pelvic curve). - Shanks: The shanks connect the blades to the handles and provide the length of the device. They . are either parallel or crossing. - Lock: The lock is the articulation between the shanks. Many different types have been designed. . - Handles: The handles are where the operator holds the device and applies traction to the fetal . head. The surgeon chooses the obstetrical/gynaecological forceps based on the anatomy of the site and the type desired, based on the type of the surgical procedure. Instrumed obstetrical forceps are made of the ASTM F 899-09 standardized Stainless Steel. The instruments are offered in non-sterile condition.
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    K Number
    K092827
    Device Name
    DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX
    Manufacturer
    DIMEDA INSTRUMENTE GMBH
    Date Cleared
    2010-01-08

    (116 days)

    Product Code
    HDA
    Regulation Number
    884.4400
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dimeda Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate vaginal delivery, provided that the cervix is fully dilated and the fetal head is positioned appropriately in the vagina. Use of the forceps is indicated for: - 0 prolonged second stage - 0 suspicion of immediate or potential fetal compromise - shortening of the second stage for maternal benefit 0
    Device Description
    The Dimeda Obstetrical Forceps is a surgical medical device for medical procedure to grasp the fetal head when it is in the vagina and bring about delivery by traction and guidance without causing injury to the mother or baby. The forceps consists of two arms which are movable. The device is manufactured from surgical stainless steel.
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    K Number
    K013747
    Device Name
    TEKNO-MEDICAL OBSTETRICAL FORCEPS
    Manufacturer
    TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO.
    Date Cleared
    2002-02-11

    (90 days)

    Product Code
    HDA
    Regulation Number
    884.4400
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    tekno-medical obstetrical forceps are used for helping delivering the baby. The forceps is consisting of two parts and you are introducing every part from the forceps(blades) seperately into the vagina.
    Device Description
    The Obstetrical forceps consist of two parts. Each of these two parts is introduced from the forceps (blades) seperately into the vagina.
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