BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇱🇺 Luxembourg

    pjur WOMAN Nude pjur med SENSITIVE glide

    K Number: K200730 · Decision Dec 17, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    242
    Applicant Total
    7
    Review Days
    272

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    Basic Information

    Device Name
    pjur WOMAN Nude pjur med SENSITIVE glide
    K Number
    K200730
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pjur Group Luxembourg S.A.
    Date Received
    March 20, 2020
    Decision Date
    December 17, 2020
    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

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    Other Clearances by Pjur Group Luxembourg S.A.

    K Number Device Name
    K260068 pjur NATURE Touch, 100 ml
    K200527 pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur
    K200731 pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5
    K141913 PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!
    K133336 PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE
    K133233 PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE