BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CANDELA URETHRAL/BLADDER SOUND

    K Number: K950633 · Decision Mar 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    0
    Applicant Total
    43
    Review Days
    21

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CANDELA URETHRAL/BLADDER SOUND
    K Number
    K950633
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5520
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Candela Laser Corp.
    Date Received
    February 13, 1995
    Decision Date
    March 6, 1995
    Product Code
    FBX
    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
    FBX Sound, Urethral, Metal Or Plastic

    Other Clearances by Candela Laser Corp.

    K Number Device Name
    K951033 ANDELA DYNAMIC COOLING DEVICE
    K955662 CANDELA Q-SWITCHED ALEXANDRITE LASERS
    K955011 CANDELA HCS 2000 URETHERAL WARMER CATHETER
    K954872 CANDELA CRYO-PROBE HOLDER
    K954934 CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE
    K953412 CANDELA MODEL PLTL-1 LASER SYSTEM
    K953294 CANDELA CRYOSYSTEM CS-5
    K950831 ALEXLAZR
    K946386 CANDELA RUBY LAZE Q-SWITCHED RUBY LASER
    K950661 CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE
    Search all 43 clearances from Candela Laser Corp. →