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

    StitchKit

    K Number: K211792 · Decision Jul 16, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    2
    Review Days
    36

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    Basic Information

    Device Name
    StitchKit
    K Number
    K211792
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Origami Surgical Inc .
    Date Received
    June 10, 2021
    Decision Date
    July 16, 2021
    Product Code
    GAM
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

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    Other Clearances by Origami Surgical Inc .

    K Number Device Name
    K221527 StitchKit