BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SMARTSHEARS

    K Number: K112400 · Decision Sep 12, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    251
    Registration Numbers
    251
    Same Product Code
    51
    Applicant Total
    1
    Review Days
    24

    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
    SMARTSHEARS
    K Number
    K112400
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nuscience Consulting and Management Group, LLC
    Date Received
    August 19, 2011
    Decision Date
    September 12, 2011
    Product Code
    FZT
    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
    FZT Cutter, Surgical

    Similar 510(k) Clearances

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

    AUTO SUTURE DISPOSABLE SURGICAL TROCAR*

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MICRINS SURGICAL SCISSOR

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SINGLE HAIR TRANSPLANT GRAFT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SPC DISPOSABLE CUTTER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SCISSORS, VARIOUS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SURGICAL SCISSORS, SET OF 3

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all