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

    SMITH & NEWPHEW ULTRABRAID II SUTURE

    K Number: K101377 · Decision Apr 8, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    242
    Same Product Code
    173
    Applicant Total
    2
    Review Days
    326

    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
    SMITH & NEWPHEW ULTRABRAID II SUTURE
    K Number
    K101377
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Newphew, Inc.
    Date Received
    May 17, 2010
    Decision Date
    April 8, 2011
    Product Code
    GAT
    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
    GAT Suture, Nonabsorbable, Synthetic, Polyethylene

    Similar 510(k) Clearances

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

    Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™

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

    HyperSuture All Green Extension Line

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

    Meniscus Versaflex

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

    Pre-Sutured Tendon

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

    ProZip Knotless Implant

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

    PowerKnot High Strength Sutures

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

    Other Clearances by Smith & Newphew, Inc.

    K Number Device Name
    K102967 SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2