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510(k) Data Aggregation

    K Number
    K193664
    Device Name
    SubQKath Catheter and Needle Set
    Manufacturer
    HK Surgical
    Date Cleared
    2020-09-09

    (253 days)

    Product Code
    BSO
    Regulation Number
    868.5120
    Why did this record match?
    Applicant Name (Manufacturer) :

    HK Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SubQKath Catheter and Needle Kit is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for subcutaneous infiltration local anesthesia, peripheral plexus anesthesia and pain management during pre-operative, perioperative and post-operative periods associated with surgical procedures.
    Device Description
    The HK SubOKath Subcutaneous Catheter is a device intended to provide a means of delivery of local analgesics into the human body via a fenestrated catheter. The device is a single lumen catheter available in a single gauge (16g) size. The distal end of the device allows for flow of analgesia into the surgical wound. The device is supplied sterile and is intended for single use.
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    K Number
    K123822
    Device Name
    KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET
    Manufacturer
    HK SURGICAL, INC.
    Date Cleared
    2013-09-27

    (289 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    HK SURGICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KleinTouch Pump is an infiltration pump used to cause a flow of fluid from an IV bag into a patient in a manner controlled manually by a health care professional. The KleinTouch pump is not intended to be used as an IV infusion pump.
    Device Description
    Device Functionality: The KleinTouch Pump is an electrically or battery operated, manually controlled, peristaltic pump using three rollers to create pumping action in a section of sterile tubing. Scientific Concept(s): The KTP is designed to specifically function with sterile single use only Klein Touch Tubing (KT20). Tubing must be primed before use. Please refer to the KT20 Instructions for Use for further details. Physical And Performance Characteristics: Device Design Display: Color Graphic LCD Dual Foot Switches With Hose - Air Activated Dimensions: 11" x 10 ¾" x 5" Weight: 8.4 lbs. Components Used: Motor Fluid Pathway Materials Silicone Inlet Hospital Power Cord Hospital Grade Plugs Barcode Reader Base, Plastic Battery Instrument Foam PCBA - Power Board PCBA, Main Circuit Board Pump, Peristaltic, 3-Roller, Fixed Clamp Switch, Rocker, Lighted Physical Properties: The Pump is intended for use in combination with the KT20 tubing. The peristaltic pump using three rollers will create pumping action in KTP20 tubing set specifically designed for the KleinTouch Pump
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    K Number
    K032802
    Device Name
    HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III
    Manufacturer
    HK SURGICAL, INC.
    Date Cleared
    2003-11-19

    (71 days)

    Product Code
    QPB, MUU
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    HK SURGICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HK Liposuction Aspiration Pump is for aesthetic body contouring.
    Device Description
    The HK Liposuction Pump is a powered suction pump/ aspirator which uses an electrically (AC) driven vacuum pump generating a negative pressure for the removal of fat/adipose(Suction Lipoplasty), soft tissue, and general surgical waste.
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    K Number
    K031432
    Device Name
    KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II
    Manufacturer
    HK SURGICAL, INC.
    Date Cleared
    2003-08-07

    (93 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    HK SURGICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Infiltration Pump is used to cause a flow of fluid from an IV bag into patient in a manner controlled manually by a health care professional. The Klein Pump is not intended to be used as an IV infusion pump.
    Device Description
    Not Found
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