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510(k) Data Aggregation

    K Number
    K100518
    Device Name
    INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
    Manufacturer
    INSTRUMED INTERNATIONAL, INC.
    Date Cleared
    2010-08-31

    (189 days)

    Product Code
    DWP
    Regulation Number
    870.4475
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSTRUMED INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INSTRUMED Vessel Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various manoeuvres of dilation and measurement of annulus and lumen diameters.
    Device Description
    Instrumed Vessel Dilators are reusable surgical instruments. To ensure the multi-purpose use of this device, different models are available. The differences can be in length, diameter, and design of the dilators. Dilators are used to check patency of vessel in coronary artery bypass procedures, to check patency of other vessels in pheripheral vascular procedures, olive shaped tips (Garrett). The surgeon chooses the instrument based on the anatomy of the vessel and the type desired, and on the type of the surgical procedure. Instrumed Vessel Dilators are made of ASTM F 899-07 standardized Stainless Steel. The instruments are offered in non-sterile condition.
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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSTRUMED INTERNATIONAL, INC.

    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
    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?
    Applicant Name (Manufacturer) :

    INSTRUMED INTERNATIONAL, INC.

    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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    K Number
    K092544
    Device Name
    INSTRUMED VASCULAR CLAMPS
    Manufacturer
    INSTRUMED INTERNATIONAL, INC.
    Date Cleared
    2009-10-26

    (68 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSTRUMED INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INSTRUMED Vascular Clamps are devices intended for temporary or partial occlusion of blood vessels during vascular surgical procedures.
    Device Description
    The Instrumed Vascular Clamps are reusable surgical instruments. To ensure the multi-purpose use of this device, many different models are available. The differences can be as follows: - . Some have ring handles with a ratchet closure to adjust the amount of tension applied to the vessel for occlusion or partial occlusion. - Bulldog style Vascular Clamps are another type of vascular cross clamp that use a spring or cross – action mechanism to apply tension to the vessel for occlusion. - The choice of jaw style depends on the surgeon's preference, based on the type and delicacy of ↓ the vessel to be occluded. The surgeon chooses the vascular clamp based on the anatomy of the site and the type of occlusion desired, based on the type and size of the blood vessels, and surgical techniques. Clamps are either fully or partially occluding an artery or vein with correct tension to produce minimal trauma to vessels. Full occlusion clamps stops blood flow entirely by covering the full vessel. Partial occlusion clamps are placed on part of the vessel to isolate the area to be worked on while allowing blood flow to continue in the rest of the vessel. Instrumed vascular clamps are made of the following standardized materials Stainless Steel ASTM F 899-07 or Titanium Alloy, The instruments are offered in non-sterile condition.
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    K Number
    K081651
    Device Name
    INSTRUMED RONGEUR
    Manufacturer
    INSTRUMED INTERNATIONAL, INC.
    Date Cleared
    2008-08-08

    (57 days)

    Product Code
    HAE
    Regulation Number
    882.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSTRUMED INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of Instrumed Rongeurs is to access, cut and bite soft tissue and bone during surgery involving the spinal column.
    Device Description
    A rongeur (Kerrison) is a strongly constructed instrument with a sharp-edged, scoop-shaped tip, used during laminectomy for gouging out bone and tissue. IVD (Intervertebral Disc) Rongeurs are used on cartilage that separates adjacent vertebrae of the spine A rongeur can be used to open a window in a bone. It is used in neurosurgery to expose areas for operation or to reduce pressure by segregating exposed areas. To ensure the multi-purpose use of this devices, many different models are available. Common names used for this kind of Rongeurs are: Kerrison, Sella Punch, IVD (Decker, MIS, Spence, Peapod, Selverstone, Williams, Cushing, Love-Gruenwald, Spurling, Cloward, Sypert, Ferris-Smith, Wilde, Hoen, Oldberg, Jackson, Schlesinger) A manual rongeur is a manually operated instrument used for cutting or biting surgery involving the skull or spinal column. All Rongeurs are offered in a non-sterile condition.
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    K Number
    K071771
    Device Name
    INSTRUMED RETRACTORS
    Manufacturer
    INSTRUMED INTERNATIONAL, INC.
    Date Cleared
    2007-08-02

    (34 days)

    Product Code
    GZT
    Regulation Number
    882.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSTRUMED INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INSTRUMED retractors are devices intended to provide minimally invasive access to the spine by ensuring the placement, positioning of the retractor down to the lamina, with its attachment to a flexible arm to provide a self locking method of access to the spinal site through which tubes, endoscopes and surgical instruments can be manipulated.
    Device Description
    Instrumed Retractors (frame, arm, blades, tubes) provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement and positioning of the retractor posterior, anterior cervical and down to the laminalspine, with its attachment to a rigid frame or a flexible arm to provide a self locking method of access to the spinal site through which a endoscope and/or surgical instruments can be manipulated.
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    K Number
    K040855
    Device Name
    INSTRUMED LAPAROSCOPE AND ACCESSORIES
    Manufacturer
    INSTRUMED INTERNATIONAL, INC.
    Date Cleared
    2004-04-16

    (14 days)

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

    INSTRUMED INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Instrumed Laparoscopes and Accessories 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 closed and minimally invasive procedures.
    Device Description
    Instrumed Laparoscopes provide illumination and visualization in diagnostic procedures and in conjunction with laparoscopic instruments (accessories) operative laparoscopic procedures
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