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

    SURGICAL RETRACTOR & ELASTIC STAYS, DISP

    K Number: K812562 · Decision Oct 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    9
    Applicant Total
    5
    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
    SURGICAL RETRACTOR & ELASTIC STAYS, DISP
    K Number
    K812562
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Humboldt Products
    Date Received
    September 8, 1981
    Decision Date
    October 2, 1981
    Product Code
    GDG
    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
    GDG Hook, Surgical, General & Plastic Surgery

    Similar 510(k) Clearances

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

    MODIFIED PGL ABSORBABLE STAPLE*

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

    SKIN HOOKS, VARIOUS TYPES

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

    RAYLOR(TM) DISSECTING HOOK

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

    BRIMFIELD CANNULATED GRASPING HOOKS

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

    SURGICAL HOOKS, VARIOUS

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

    MIDDLE EAR PICKS, HOOKS CURETTES,

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

    Other Clearances by Humboldt Products

    K Number Device Name
    K832540 DRUMTO STAPES PROSTHESIS
    K823483 STAINLESS STEEL PISTONS
    K813616 TEKNA MED MYRINGOTOMY DISPOS-OTO KIT
    K802587 OTOLOGICAL VENTILATION TUBES