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

    SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture

    K Number: K222944 · Decision Oct 18, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    40
    Applicant Total
    2
    Review Days
    753

    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
    SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture
    K Number
    K222944
    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
    September 26, 2022
    Decision Date
    October 18, 2024
    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

    Similar 510(k) Clearances

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

    Sofsilk™ Coated Braided Silk Suture

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Non absorbable Surgical Silk Suture

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Surgical Sutures with or without Needle

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SafePath Suturing System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SILK Surgical Suture

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Safepath Medical, Inc.

    K Number Device Name
    K180701 SafePath Suturing System