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510(k) Data Aggregation

    K Number
    K210394
    Device Name
    Electrosurgical accessory
    Manufacturer
    Dornier MedTech America Inc.
    Date Cleared
    2021-05-19

    (98 days)

    Product Code
    FAS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dornier MedTech America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dornier Bipolar Cable is indicated to be used with a compatible electrosurgical generator and an HF electrode for endoscopic treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current.
    Device Description
    The Dornier Bipolar Cable is a sterile, single use, disposable device that allows connection of an electrosurgical generator to an HF electrosurgical resection and vaporization electrode. The outer body of the Dornier Bipolar Cables are constructed of a medical grade thermoplastic elastomer. The cable consists of a double wire zip cord with one plug end which has four (4) banana and one (1) straight pin, style of connector that is then attached to the generator. The other end is separated and has two (2) overmolded connectors, one male pin on a wire and one female pin on a wire which are compatible with the HF Electrode.
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    K Number
    K190312
    Device Name
    Dornier Ureteral Stent
    Manufacturer
    Dornier MedTech America Inc.
    Date Cleared
    2019-11-15

    (276 days)

    Product Code
    FAD
    Regulation Number
    876.4620
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dornier MedTech America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dornier CASCADE Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.
    Device Description
    The Dornier CASCADE Ureteral Stents are sterile, single-use devices. The stents are available in 4.9 to 8.0 French (Fr) diameter, with lengths ranging from 14.0 to 32.0 centimeters (cm). The stents are constructed of a thermoplastic polyurethane elastomer. The base polyurethane material is compounded with BaSO4 to render the stent radiopaque under x-ray fluoroscopy. Drainage holes extend along the body of the stent as well as on the pigtails to provide drainage. The stents are secured in the urinary tract with pigtail loops on the proximal and distal ends. A monofilament tether for repositioning and removal of the device is located on the proximal pigtail (bladder end) of the stent. Along the stent are graduation marks to provide visualization during stent advancement and placement. The CASCADE Ureteral Stent includes a pigtail straightener, a small polymer tube to aid in placement over a wire guide. The pigtail straightener is removed prior to use. The CASCADE Ureteral Stents are labeled for a maximum 30day indwell time. The stents are packaged into a pre-formed tray and sealed within a Tyvek pouch. The individually sealed Tyvek pouches are labeled with identification labeling and then packaged into a corrugated shipping box. The packaged stents are sterilized by a contract sterilizer using ethylene oxide.
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