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510(k) Data Aggregation

    K Number
    K223689
    Device Name
    Disposable Needle Guides and Grids
    Manufacturer
    Advance Medical Designs, Inc.
    Date Cleared
    2023-08-02

    (236 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Advance Medical Designs, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Needle Guides and Grids are used to assist and aid physicians in performing an endocavity diagnosis ultrasound needle guided procedure using guided intervention fixed guiding for the precise insertion of linear instruments, such as needle Guides and Grids are designed to aid adult patient population, in need of a biopsy of an internal organ, or internal delivery or removal of fluid within the body cavity, via the use of a needle, during an ultrasound procedure by retaining the needle tip and barrel within the ultrasound beam.
    Device Description
    Advance Medical Designs' disposable needle guides & grids devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. The Needle Guides and Grids are packaged separately, or within kits, provided sterile, and are labelled as single use only. Each disposable needle guide & grid contains a bracket and needle adapter. Each kit includes a disposable needle guide, a 20ml packet of ASonic® sterile gel, two latex free elastic bands, and a transducer cover (Latex or Latex-Free). The needle guides are non-invasive and have contact with only intact skin.
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    K Number
    K163050
    Device Name
    Advance Medical Designs, Inc. Sterile Ultrasound Gel
    Manufacturer
    ADVANCE MEDICAL DESIGNS, INC.
    Date Cleared
    2017-10-25

    (358 days)

    Product Code
    MUI
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCE MEDICAL DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Advance Medical Designs, Inc. Sterile Ultrasound Gel is intended for general use as a sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient's intact skin prior to initiating an ultrasound examination. It is indicated for prescription use only.
    Device Description
    Advance Medical Designs, Inc. Sterile Ultrasound Gel consists of deionized water, glycerin, butylene glycol, glyceryl acrylic acid copolymer, propylene glycol, carbomer, phenoxyethanol, cellulose gum, sodium hydroxide, hydroxyethlcellulose, ethylhexylglycerin. It is a type of conductive medium (i.e.) scanning gel used in ultrasound therapeutic and diagnostic imaging techniques. A scanning gel acts as a couplant that provides an acoustic pathway between transducer and the intact skin. In addition, the gel eliminates air (a disruptive influence) from the interface and adapts to the contours of the probe to the intact skin. The major characteristics of Advance Medical Designs, Inc. Sterile Ultrasound Gel: - Hypoallergenic, non-irritating - Water soluble, non-staining and easily cleanable - Free from formaldehyde and salt - Does not contain oil or fatty matter - No toxic effects - Vacuum treated production - Produced as a completely harmless material - Does not damage the probe - Does not contain air bubbles
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    K Number
    K053495
    Device Name
    EQUIPMENT SLUSH DRAPE
    Manufacturer
    ADVANCE MEDICAL DESIGNS, INC.
    Date Cleared
    2006-03-16

    (91 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCE MEDICAL DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Advance Medical Designs equipment drapes are used to cover a variety of surgical and non-surgical equipment in various clinical settings. It is to be used in general and Endoscopic surgery for use with saline.
    Device Description
    The Advance Medical Designs, Inc Equipment Drapes consist of polyurethane film that is cut and configured to specification. Packaged in a pouch to act as a sterile barrier. These equipment drapes are equivalent to other equipment drapes currently being marketed for the same intended use
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    K Number
    K011265
    Device Name
    ULTRASOUND TRANSDUCER COVER
    Manufacturer
    ADVANCE MEDICAL DESIGNS, INC.
    Date Cleared
    2001-10-30

    (188 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCE MEDICAL DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K012168
    Device Name
    ADVANCE MEDICAL DESIGNS FLUID POUCH
    Manufacturer
    ADVANCE MEDICAL DESIGNS, INC.
    Date Cleared
    2001-09-18

    (68 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCE MEDICAL DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Advance Medical Designs Fluid Pouch is a body fluid drainage device. The Fluid Pouch is used for Hysteroscopy, Cystoscopy, Urology, and Brachytherapy procedures.
    Device Description
    Not Found
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    K Number
    K011422
    Device Name
    SURGICAL DRAPES
    Manufacturer
    ADVANCE MEDICAL DESIGNS, INC.
    Date Cleared
    2001-07-10

    (62 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCE MEDICAL DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003670
    Device Name
    PATIENT DRAPE, SURGICAL
    Manufacturer
    ADVANCE MEDICAL DESIGNS, INC.
    Date Cleared
    2001-01-26

    (59 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCE MEDICAL DESIGNS, INC.

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

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