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    K Number
    K181673
    Device Name
    Rigi10 Malleable Penile Prosthesis
    Manufacturer
    Rigicon Inc.
    Date Cleared
    2019-04-15

    (294 days)

    Product Code
    FAE
    Regulation Number
    876.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rigicon Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The malleable penile prosthesis is indicated for implantation into the corpora cavernosa of the penis in men who are diagnosed with erectile dysfunction. The prosthesis is implanted to provide adequate penile rigidity for sexual intercourse. The prosthesis is designed for the treatment of organic erectile dysfunction in men due to: Pelvic fracture, Spinal cord injury or disease, Prostatectomy,Multiple sclerosis, Diabetes mellitus, Arteriosclerosis, Hypertensive vascular disease, Priapism, Peyronie's disease, Selectively for psychogenic impotence.
    Device Description
    Rigi10 malleable penile prosthesis is a sterile, non-pyrogenic, single-use surgical implant. The device core consists of a malleable stainless-steel core, with titanium caps on both ends, and a PTFE (Polytetrafluoroethylene) tube cover. The entire outside surface of the cylinder is made out of silicone. The malleable stainlesssteel core enables the prosthesis to be moved into an erect position when desired and also enables the concealment of the prosthesis under clothing. All components consist of implantable, biocompatible materials. The device consists of two cylinders, and extenders. The cylinders are surgically implanted, one into each corpus cavernosum, to provide penile rigidity. The prosthesis comes in two lengths. This includes 23 cm and 25 cm. The length is determined by the diameter of the prosthesis. Rigi10 Malleable Penile Prosthesis is available in five different diameter sizes; 9 mm, 10 mm, 11 mm, 12 mm, and 13 mm. Cylinders with 9 mm and 10 mm diameters are available in 23 cm length while cylinders with 11mm, 12 mm and 13 mm diameters are available in 25 cm length. There are four extenders (two pieces of 0.5 cm and two pieces of 1.0 cm) included in each product package. The extenders are accessories of the device and are available for adjusting the length of the prosthesis to match the total corporal measurement of the patient.
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