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

    Durex Silicone

    K Number: K143532 · Decision Jul 31, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    242
    Applicant Total
    5
    Review Days
    231

    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
    Durex Silicone
    K Number
    K143532
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reckitt Benckiser, LLC
    Date Received
    December 12, 2014
    Decision Date
    July 31, 2015
    Product Code
    NUC
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NUC Lubricant, Personal

    Similar 510(k) Clearances

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

    PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    pjur NATURE Touch, 100 ml

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Julva Velvé Water-Based Personal Lubricant

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Water-based lubricant

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Reckitt Benckiser, LLC

    K Number Device Name
    K173504 K-Y Silicone
    K151884 K-Y Marilyn Pleasure Gel
    K131643 DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT
    K140193 DUREX EMBRACE PERSONAL LUBRICANT