BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇾 Malaysia

    Carex Hybrid Personal Lubricant

    K Number: K223519 · Decision Aug 11, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    242
    Applicant Total
    8
    Review Days
    261

    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
    Carex Hybrid Personal Lubricant
    K Number
    K223519
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Karex Industries Sdn. Bhd.
    Date Received
    November 23, 2022
    Decision Date
    August 11, 2023
    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 Karex Industries Sdn. Bhd.

    K Number Device Name
    K150743 Water Based Personal Lubricant with Flavours
    K141059 NATURAL RUBBER LATEX MALE CONDOMS
    K132597 BLACK COLOURED CONDOM
    K113056 ORANGE COLORED CONDOMS ORANGE SCENT
    K113061 LARGE/EXTRA LAGRE CONDOM
    K081886 KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED
    K070830 MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)