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510(k) Data Aggregation

    K Number
    K012199
    Device Name
    DIGICAP
    Manufacturer
    HUMANA USA, INC.
    Date Cleared
    2001-12-19

    (159 days)

    Product Code
    GAB, KGO
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GAB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DigiCap™ is a protective finger guard accessory to the surgeon's glove. 1. Intended to provide needlestick and suture/scalpel protection during a variety of surgical procedures. DigiCap™ is a protective finger guard accessory to the surgeon's glove. It is used on the finger or thumb of the non-dominant hand usually used to retract, stabilize, compress, and position tissue during surgical procedures. 2. Facilitate suture handling and placement.
    Device Description
    The DigiCAP is an accessory to surgeon's gloves. This product is made from a resin and is of a rigid configuration whereas surgeons gloves are usually prepared from latex or vinyl materials.
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    K Number
    K980988
    Device Name
    AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)
    Manufacturer
    AXYA MEDICAL, INC.
    Date Cleared
    1998-05-11

    (55 days)

    Product Code
    GAB, DAT
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GAB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ASLS is indicated for the placement of synthetic monofilament sutures in soft tissues and for the ligation of tubular structures wherever conventional monofilament sutures or surgical staples are appropriate. The ASLS is indicated for use in both traditional open surgery and ondoscopic surgical procedures.
    Device Description
    The Axya Automatic Suturing and Ligating System (ASLS) is a device for the placement of sutures in soft tissue to close either traumatic or surgically produced wounds. It uses curved, hollow needles to place the suture through soft tissue structures and secures the suture loop with an ultrasonic weld. The ultrasonic energy source used to weld and secure the suture loop is similar to the energy source used in the UltraCision Harmonic Scalpel. The device is sterilized by exposure to gamma irradiation.
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