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

    ERECAID SYSTEM/STAY EREC SYSTEM

    K Number: K974173 · Decision Feb 25, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    86
    Applicant Total
    7
    Review Days
    112

    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
    ERECAID SYSTEM/STAY EREC SYSTEM
    K Number
    K974173
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5020
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imagyn Medical Technologies, Inc.
    Date Received
    November 5, 1997
    Decision Date
    February 25, 1998
    Product Code
    LKY
    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
    LKY Device, External Penile Rigidity

    Similar 510(k) Clearances

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

    NANMA VACUUM PUMP PROXZEK MODEL 2M9498S

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VACURECT VACUUM CONSTRICTION DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NANMA ADJUSTABLE CONSTRICTION RING

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NANMA VACUUM PUMP

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MODIFICATION TO NANMA VACUUM PUMP

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NANMA ADJUSTABLE CONSTRICTION RING

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Imagyn Medical Technologies, Inc.

    K Number Device Name
    K032491 ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR
    K012706 IM2001 PULSE OXIMETER
    K010166 IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
    K991526 ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501
    K980096 OAC (OPTICAL ASPIRATING CURETTE)
    K980291 IMPOWER EXTERNAL VACUUM SYSTEM