BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER

    K Number: K902585 · Decision Aug 27, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    26
    Applicant Total
    9
    Review Days
    76

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    Basic Information

    Device Name
    UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER
    K Number
    K902585
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5520
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Advanced Surgical Intervention, Inc.
    Date Received
    June 12, 1990
    Decision Date
    August 27, 1990
    Product Code
    KOE
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KOE Dilator, Urethral

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    Other Clearances by Advanced Surgical Intervention, Inc.

    K Number Device Name
    K954215 MINIGUARD
    K926110 ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT
    K930361 ASI CYSTOLASE LASER CYSTOSCOPE
    K921990 ASI UROPLASTY LASER CYSTOSCOPE
    K901336 ASI HEMOSTASIS CATHETER
    K896713 ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.
    K895182 ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY
    K874530 URETHRAL DILATOR ENDOSCOPE