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510(k) Data Aggregation

    K Number
    K190378
    Device Name
    Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix
    Manufacturer
    Date Cleared
    2019-05-24

    (94 days)

    Product Code
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bioncise NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Spirotome Endo is a family of large core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue. The Spirotome Endo is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities of the internal female reproductive organs such as uterus, ovaries, and retroperitoneal lymph nodes.
    Device Description
    The Spirotome Endo is a core biopsy device. It consists of a stainless steel receiving needle with a helical shape, stainless steel cutting cannula, and a polypropylene releasing element. The receiving needle is inserted though the cutting cannula prior to advancing to the biopsy site. The receiving needle is rotated clockwise into the tissue using the plastic hub on the proximal end. The cutting cannula is then rotated clockwise to separate the biopsy sample from the surrounding tissue. Following retraction from the biopsy site, the releasing element is used to remove the tissue sample from the receiving needle. The receiving needle is rotated counter-clockwise to release the tissue. The Spirotome Endo is operated manually. The Spirotome Endo has four variants: one 8 gauge, and two 14 gauge needles. The receiving needle is 375 mm in length and the cutting cannula is 325 mm long. The helical needle is 18 mm long in all the variants except one 14 gauge variant, where it is 10 mm long. The device is provided sterile and is for single-use only.
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