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510(k) Data Aggregation

    K Number
    K121186
    Device Name
    RADIAL JAW 4 PULMONARY BIOPSY FORCEPS
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2012-05-16

    (28 days)

    Product Code
    BWH
    Regulation Number
    874.4680
    Why did this record match?
    Product Code :

    BWH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Radial Jaw 4 Pulmonary Biopsy Forceps are specifically designed to collect tissue endoscopically for histologic examination. These instruments should not be used for any purpose other than their intended use.
    Device Description
    The Radial Jaw 14 4 Pulmonary Biopsy Forceps (RJ4 Pulmonary) are sterile, single-use devices. The Radial Jaw'14 4 Pulmonary Biopsy Forceps are available in two jaw sizes: RJ4 Pulmonary Large Capacity is compatible with a 2.8mm or larger working channel endoscope and the RJ4 Pulmonary Standard Capacity is compatible with a 2.0mm or larger working channel endoscope. The RJ4 Pulmonary Large Capacity is only available without a needle. The RJ4 Pulmonary Standard Capacity is available with or without a needle. Both the RJ4 Pulmonary Large Capacity and Standard Capacity devices have a 100cm working length. To operate the device, the user slides the spool back and forth over the handle body to open and close the jaws. The spool simultaneously actuates the dual pull wires, each of which run the length of the device and terminate with a connection to the jaw. The dual pull wire design allows the jaws to pivot, thus enabling tissue acquisition with a tangential approach if desired. Using the RJ4 Pulmonary Biopsy Forceps the user can obtain a tissue sample by opening the jaws, pressing the jaws against the biopsy site, closing the jaws, and pulling the jaws away from the biopsy site.
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    K Number
    K102336
    Device Name
    RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2011-01-24

    (159 days)

    Product Code
    BWH
    Regulation Number
    874.4680
    Why did this record match?
    Product Code :

    BWH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Radial Jaw 4 Pulmonary Biopsy Forceps are specifically designed to collect tissue endoscopically for histologic examination. These instruments should not be used for any purpose other than their intended use.
    Device Description
    The Radial Jaw™ 4 Pulmonary Biopsy Forceps (RJ4 Pulmonary) are sterile, single-use (disposable) devices. The devices are packaged in a tyvek pouch, which is packaged into a carton box. The Radial Jawns 4 Pulmonary Biopsy Forceps are available in two jaw sizes: RJ4 Pulmonary Large Capacity is compatible with a 2.8mm or larger working channel endoscope and the RJ4 Pulmonary Standard Capacity is compatible with a 2.0mm or larger working channel endoscope. The RJ4 Pulmonary Large Capacity is only available without a needle, The RJ4 Pulmonary Standard Capacity is available with or without a needle. Both the RJ4 Pulmonary Large Capacity and Standard Capacity devices have a 100cm working length. To operate the device, the user slides the spool back and forth over the handle body to open and close the jaws. The spool simultaneously actuates the dual pull wires, each of which run the length of the device and terminate with a connection to the jav. The dual pull wire design allows the javs to pivot, thus enabling tissue acquisition with a tangential approach if desired. Using the RJ4 Pulmonary Biopsy Forceps the user can obtain a tissue sample by opening the jaws, pressing the jaws against the biopsy site, closing the jaws, and pulling the jaws away from the biopsy site.
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    K Number
    K022398
    Device Name
    REUSABLE BRONCHIAL BIOPSY FORCEPS
    Manufacturer
    BALLARD MEDICAL PRODUCTS
    Date Cleared
    2002-10-11

    (80 days)

    Product Code
    BWH
    Regulation Number
    874.4680
    Why did this record match?
    Product Code :

    BWH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to remove, by cutting, a specimen of tissue for microscopic examination from the lungs or bronchial passageways. Patient population; Any patient demonstrating an abnormality or condition indicative of malignancy or benign obstruction as noted through bronchoscopy, x-ray, MRI, etc.
    Device Description
    Figure A-1 depicts all but a few reusable biopsy forceps designs. All operate on a 4-bar linkage arrangement as shown. Transverse motion of the control cable results in the pendulum motion of the handle consists of a slide, finger spool or finger ring arrangement and a thumb ring. The jaws are actuated by transverse motion of the finger spool that connects to the control cable is connected to the clevis. The linkages are hinged on small pins, the jaws rotate about an axle pin that is supported by the fork. With the exception of the handle, all the components are fabricated from ASTM 302, 303 or 304 stainless steel. The handle components are fabricated from a suitable material able to withstand several reprocessing cycles.
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