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

    DISPOSABLE SKIN STAPLER

    K Number: K830768 · Decision Apr 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    5
    Applicant Total
    6
    Review Days
    32

    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
    DISPOSABLE SKIN STAPLER
    K Number
    K830768
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4320
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Surgeons Choice, Inc.
    Date Received
    March 11, 1983
    Decision Date
    April 12, 1983
    Product Code
    FZQ
    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
    FZQ Clip, Removable (Skin)

    Similar 510(k) Clearances

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

    RANEY CLIP

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

    LEUKOCLIP(R)

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

    ONE TIME DISPOSABLE SKIN STAPLER

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

    SURGICAL PRODUCTS, SKIN STAPLE REMOVER

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

    COMPLETE

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

    Other Clearances by Surgeons Choice, Inc.

    K Number Device Name
    K851121 PI-PHEUMO INTESTINAL INSTRUMENT SET
    K851122 PI-PNEUMO INTESTINAL STAPLING CARTRIDGE
    K843399 SURGEONS CHOICE PI VASCULAR STAPLING
    K823776 PI-PNEUMO-INTESTINAL INSTRUMENT SET
    K813170 ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER