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

    CENTURION SKIN STAPLE REMOVER

    K Number: K822365 · Decision Aug 27, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    21

    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
    CENTURION SKIN STAPLE REMOVER
    K Number
    K822365
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4760
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Tri-State
    Date Received
    August 6, 1982
    Decision Date
    August 27, 1982
    Product Code
    GDT
    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
    GDT Staple, Removable (Skin)

    Similar 510(k) Clearances

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

    STAPLE REMOVAL KIT

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

    VISISTAT STAPLER

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

    MANIPLER DISPOSABLE SKIN STAPLER

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

    SKIN STAPLE REMOVER KIT

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

    QUALTEX SKIN STAPLE EXTRACTOR

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

    AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*

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