BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla

    K Number: K213547 · Decision Dec 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    3
    Review Days
    45

    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
    SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla
    K Number
    K213547
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ttk Healthcare Limited
    Date Received
    November 8, 2021
    Decision Date
    December 23, 2021
    Product Code
    HIS
    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
    HIS Condom

    Similar 510(k) Clearances

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

    Male Latex Condom HA

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

    LifeStyles® HydraFeel Natural Rubber Latex Condom

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

    Natural rubber latex male condom

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

    Lelo Hex Lubricated Natural Rubber Latex Condom

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

    Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)

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

    0.04 ZERO ZERO FOUR Male Latex Condom

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

    Other Clearances by Ttk Healthcare Limited

    K Number Device Name
    K230049 SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT
    K202403 SKORE (Colors & Flavors), SKORE (Colors)