BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

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

    K Number: K252914 · Decision Jun 9, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    242
    Applicant Total
    3
    Review Days
    270

    Basic Information

    Device Name
    Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
    K Number
    K252914
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hathor Professional Skincare , Ltd.
    Date Received
    September 12, 2025
    Decision Date
    June 9, 2026
    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 Hathor Professional Skincare , Ltd.

    K Number Device Name
    K250629 Sutil Rich Personal Lubricant
    K241443 Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)