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

    SafePath Suturing System

    K Number: K180701 · Decision Jun 25, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    40
    Applicant Total
    2
    Review Days
    101

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    Basic Information

    Device Name
    SafePath Suturing System
    K Number
    K180701
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5030
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Safepath Medical, Inc.
    Date Received
    March 16, 2018
    Decision Date
    June 25, 2018
    Product Code
    GAP
    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
    GAP Suture, Nonabsorbable, Silk

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    Other Clearances by Safepath Medical, Inc.

    K Number Device Name
    K222944 SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture