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

    RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM

    K Number: K941781 · Decision Aug 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    20
    Review Days
    136

    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
    RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM
    K Number
    K941781
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dacomed Corp.
    Date Received
    April 11, 1994
    Decision Date
    August 25, 1994
    Product Code
    LIL
    Advisory Committee
    Unknown
    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
    LIL Monitor, Penile Tumescence

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LIL), ordered by most recent decision date.

    RIGIDOMETER, MODEL DIR-4U

    FDA 510(k)
    FDA Unclassified ·Unknown

    PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)

    FDA 510(k)
    FDA Unclassified ·Unknown

    PREFTEST PROFESSIONAL SUITE

    FDA 510(k)
    FDA Unclassified ·Unknown

    MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    DIGITAL INFLECTION RIGIDOMETER (DIR)

    FDA 510(k)
    FDA Unclassified ·Unknown

    VISER PENILE TUMESCENCE MONITOR

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Dacomed Corp.

    K Number Device Name
    K953640 DUNA II PENILE PROSTHESIS
    K920409 DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE
    K920420 DURA II PENILE PROSTHESIS
    K912344 MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS
    K900774 DACOMED NEGATIVE PRESSURE ERECTION DEVICE
    K885323 DACOMED EXTERNAL MALE CONTINENCE DEVICE
    K880391 DACOMED CYSTOMETER
    K871653 DURAPHASE PENILE PROSTHESIS
    K870320 DACOMED PENILE PROSTHESIS SIZER
    K854118 DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS
    Search all 20 clearances from Dacomed Corp. →