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510(k) Data Aggregation

    K Number
    K113028
    Device Name
    MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS
    Manufacturer
    MEDISISS
    Date Cleared
    2011-12-20

    (70 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDISISS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MEDISISS Reprocessed Shavers and Burs are powered arthroscopic accessories intended for use in orthopedic joint surgery.
    Device Description
    Arthroscopic devices reprocessed by MEDISISS include burs and blades at the end of a long rod that rotates within a hollow stainless steel housing. The housing has an opening on one side of the distal end, allowing the cutting tip to resect tissue while protecting adjacent material with the housing on the opposite side of the bur or blade. This system attaches to a motorized hand piece that drives the internal bur or blade inside the outer housing and provides suction to pull the cut tissue away from the surgical site. Devices are provided sterile.
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    K Number
    K100543
    Device Name
    MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01
    Manufacturer
    MEDISISS
    Date Cleared
    2010-07-23

    (148 days)

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

    MEDISISS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MEDISISS Reprocessed ENT Ablation Wands (Coblators) are indicated for coagulation, ablation, resection, of soft tissue and hemostasis of blood vessels in otoloaryngology (ENT) procedures including: tonsillectomy/adenoidectomy and soft tissue reduction.
    Device Description
    The device is a high frequency, bipolar ablation wand with suction capability that contains an integrated electrical cable and integrated saline delivery system.
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    K Number
    K081559
    Device Name
    GENESIS
    Manufacturer
    MEDISISS
    Date Cleared
    2008-08-28

    (86 days)

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

    MEDISISS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Genesis is indicated for use in surgical procedures (general neurosurgical, laparoscopic, orthopedic, gynecologic, etc.) where monopolar electrosurgical cutting and coagulation are normally used. The Genesis instruments are an alternative to conventional monopolar electrosurgical electrodes used for these indications.
    Device Description
    The Genesis is an instrument intended for use as a monopolar electrosurgical accessory. The device reduces the smoke emitted into the surgical area, uses lower power with less tissue damage and the outer layer provides a surface that reduces tissue accumulations and facilitates removing tissue residues, such as eschar, that may accumulate during use. Genesis devices are intended for use with monopolar electrosurgical accessories and will be packaged separately. Genesis instruments will also fit in currently marketed electrosurgical pencils offered by other manufacturers.
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    K Number
    K042659
    Device Name
    MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS
    Manufacturer
    MEDISISS
    Date Cleared
    2005-02-14

    (139 days)

    Product Code
    NON, REG
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDISISS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MediSISS Reprocessed Non-electric Biopsy Forceps are intended to be used to remove polyps, and obtain a specimen of tissue for microscopic examination.
    Device Description
    MediSISS Reprocessed Non-electric GI Biopsy Forceps are designed for endoscopic use to retrieve tissue samples for microscopic inspection. Forceps outer diameters range from 2,2mm to 2.5mm and working lengths vary from 160cm. A syringe-like proximal handle opens and closes the distal instrument jaws, that are available in multiple design configurations such as Oval, Alligator, Smooth, or Fenestrated with and without a needle. The working length of the biopsy forceps is coated with a plastic sheath to decrease friction.
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    K Number
    K030598
    Device Name
    MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS
    Manufacturer
    MEDISISS
    Date Cleared
    2004-01-23

    (332 days)

    Product Code
    NLQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDISISS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SISS d.b.a. MediSISS™ Reprocessed Ultrasonic Surgical Instruments are intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel instruments. The instruments are used in general, pediatric, thoracic, gynecologic, urologic, and other open and endoscopic surgeries for the transection, dissection, and coagulation of tissue(s).
    Device Description
    Reprocessed Ultrasonic Surgical Instruments consist of hand-manipulated devices, with or without rotation capability, with or without cutting ability. The handpiece handles are connected to the distal end-effector by a narrow-diameter metal barrel or shaft. The distal end of the device consists of a scalpel with a variety of end configurations including Flat, Cutting, and Blunt or a combination of the same. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula or used to be used in open surgery. The end-effectors are usually operated by the handpiece handles. The handles may be designed to be suppressed and released to activate the instruments end-effector. Similarly the handle may incorporate a button or switch to activate the end-effectors. The device's shaft may be designed to (depending on the device model and type) be rotated (up to 360°) either direction (by manipulating controls located on the handle.)
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    K Number
    K030919
    Device Name
    SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES
    Manufacturer
    MEDISISS
    Date Cleared
    2003-07-03

    (101 days)

    Product Code
    NLR
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDISISS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SISS Inc. (d.b.a. MediSISS) Reprocessed electrosurgical instruments have applications in a variety of minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, and/or to facilitate coagulation, transection, resection, mobilization, and dissections of tissue.
    Device Description
    Reprocessed Electrosurgical Instruments may consist of hand-manipulated devices with electrocautery capability and with or without rotation capability. The handpiece handles are connected to the distal end-effector by a narrow-diameter insulated barrel or shaft. The distal end of the device consists of a variety of distal end configurations including: dissectors (straight or curved), graspers, scissors (curved, hooked, or metzenbaum), shears, and cutting or dissecting forceps. The devices may be monopolar, bipolar, or tripolar. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. If the instrument has a scissor or jaw end-effector these are opened and closed using the handles. The device's insulated shaft may be designed to (depending on the device model and type) be rotated (up to 360°) either direction (using a knob on the handle.) The jaws of some models may be rotated by manipulating controls on the handpiece. Grasper and clamp models may have manipulating jaws operated at the handpiece to lock and hold tissue.
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