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510(k) Data Aggregation

    K Number
    K080341
    Device Name
    ENDODRAPE(TM)
    Manufacturer
    VORTEK SURGICAL, LLC
    Date Cleared
    2008-07-21

    (164 days)

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

    VORTEK SURGICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the ENDODRAPE™ Upper Endoscopy Drape is to protect patients, staff and equipment from bodily secretions and to maintain a cleaner procedural site during non-sterile upper gastrointestinal endoscopic procedures. The device is a single use disposable drape that is provided non-sterile. The device can, however, be EtO (ethylene oxide) sterilized by the end user prior to use.
    Device Description
    The Vortek Surgical ENDODRAPE™ Upper Endoscopy Drape is a single use, disposable covering intended for use in non-sterile surgical and diagnostic procedures. The ENDODRAPE™ Upper Endoscopy Drape consists of a non-woven surgical drape measuring 38" x 54" (97cm X 137cm), similar to other surgical drapes currently being marketed. As with the predicate colonoscopy drape, the ENDODRAPE™ Upper Endoscopy Drape is intended to protect patients, staff, and equipment from bodily secretions present during non sterile endoscopic procedures, with the only variation in size and configuration to provide optimal protection for upper gastrointestinal endoscopic procedures. The ENDODRAPE™ Upper Endoscopy Drape consist of materials commonly used for medical drape manufacturing including commercially available non-woven surgical drape fabric, Krayton, Velcro, LDPE, medical grade tapes, SMS, medical grade adhesives, hot melt, cold glue. The drape is intended for non-sterile use by the end-user and is supplied in individual heat sealed polybags.
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    K Number
    K070406
    Device Name
    ENDODRAPE
    Manufacturer
    VORTEK SURGICAL, LLC
    Date Cleared
    2007-07-30

    (168 days)

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

    VORTEK SURGICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Endodrape™ surgical and diagnostic procedure drape manufactured by Vortek Surgical is for patients receiving and/or medical professionals performing a non-sterile diagnostic procedure for colonoscopies to help protect the patient and staff from bodily secretions and to maintain a cleaner procedural site. The device is a single use disposable drape that is provided non-sterile. The device can, however, be EtO (ethylene oxide) sterilized by the end user prior to use.
    Device Description
    The Endodrape™ surgical and diagnostic procedure drapes manufacture by Vortek Surgical, Inc. are non-sterile, single use, disposable barriers intended to be used by medical professionals as a protective patient covering; to protect clinical staff and equipment from patient secretions; and help maintain a cleaner procedural site. The drapes are blue in color and are a non-woven fabric that will be manufactured under private label to Vortek Surgical. The Endodrape™ fabric itself is a repellant treated, non-woven fabric manufactured under the trade name of Sontara by the contract manufacturer to Vortek Surgical, Inc. There are no reinforced areas of the drape. The drape is 0.13 inch thick and measures 43" x 49" and is without any areas of reinforcement. The fibers used in the drape are mechanically bonded together.
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