Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K012033
    Device Name
    MULTIFUNCTION ENDOSCOPIC INSTRUMENT
    Date Cleared
    2001-09-20

    (83 days)

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

    SEEDLING ENTERPRISES. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MEI is a laparoscopic and endoscopic, bipolar, electrosurgical device intended for grasping, dissecting, coagulating and transecting tissue in laparoscopic and open procedures. The types of surgery indicated are: General surgery Laparoscopic procedures Endoscopic procedures Laryngeal coagulation Orthopedic coagulation Thorascopic coagulation Neurosurgical coagulation Gynecological coagulation, (except for use in female sterilization) Ear, Nose and Throat coagulation
    Device Description
    The Multifunction Endoscopic Instrument is a single patient use device, which is a combination scissors and bipolar coagulator-grasper. It is intended for use in canjunction with presently employed 5-10mm trocar cannulae. The instrument grasping and cutting functions are operated easily using one hand. The device is indicated for use in a variety of open and minimally invasive procedures. It is designed to facilitate grasping, mobilization, dissection, coagulation and transection of tissue. The grasping and cutting functions of the distal end are accomplished by employing three elements. - A central stationary member serves as both a scissors blade and a forceps jaw. - A separate scissors blade and a forceps jaw are attached to the some that they can be independently pivoted to open and close thereby performing the cutting and grasping functions. - The pivoting scissors blade and forceps jaw are connected to the handle and actuated via linkages.
    Ask a Question

    Ask a specific question about this device

    K Number
    K010710
    Device Name
    SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES
    Date Cleared
    2001-05-18

    (70 days)

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

    SEEDLING ENTERPRISES. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

    K Number
    K002841
    Device Name
    COOL-TEC ELECTRODES
    Date Cleared
    2000-12-08

    (87 days)

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

    SEEDLING ENTERPRISES. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

    K Number
    K001723
    Device Name
    COOL-TEC ELECTRODES
    Date Cleared
    2000-07-19

    (43 days)

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

    SEEDLING ENTERPRISES. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1