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510(k) Data Aggregation

    K Number
    K123478
    Device Name
    STINGRAY BIPOLAR FORCEPS
    Date Cleared
    2013-05-10

    (178 days)

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

    STINGRAY SURGICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch. The Stingray Forceps have not been shown to be effective for tubal stenlization or tubal coagulation for sterilization procedures and should not be used for these procedures.
    Device Description
    These devices are bipolar forceps design for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate selected tissues. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch. They are constructed of stainless steel, a nylon coating, and a non-stick tip. The devices are provided non-sterile and must be autoclaved prior to use.
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    K Number
    K102752
    Device Name
    STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS
    Date Cleared
    2011-11-09

    (412 days)

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

    STINGRAY SURGICAL PRODUCTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Designed to grasp, manipulate and coagulate selected tissue for single use in general surgical procedures. These forceps can be sold with or without irrigation and are provided sterile. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator and irrigation module. Stingray Ultralite Disposable Irrigation Forceps can be used with bipolar coagulation current. Coagulation is achieved using electrosurgical energy generated by the electro surgical generator unit and activated by a footswitch. The Stingray Ultralite Disposable Irrigation Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
    Device Description
    These devices are disposable bipolar forceps design for single use in general surgical procedures. They are connected through a suitable birolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate, or irrigate selected tissues. The semi rigid irrigation tube is designed to carry nonpyrogenic fluid through the instrument and outputted to the tip end. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch. They are constructed of stainless steel, a nylon coating, and a non-stick alloy tip. The devices are provided sterile ethylene oxide (ETO) and in sterile packs.
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    K Number
    K083162
    Device Name
    STINGRAY ELECTROSURGICAL FORCEPS
    Date Cleared
    2009-01-12

    (77 days)

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

    STINGRAY SURGICAL PRODUCTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current. Coagulation is achieved using electrosurgical energy generated by the electro surgical generator unit and activated by a footswitch. The Stingray Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
    Device Description
    These devices are bipolar forceps design for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate selected tissues. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch. They are constructed of stainless steel, a nylon coating, and a non-stick tip. The devices are provided non-sterile and must be autoclaved prior to use.
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