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

    LEE ASPIRATION NEEDLE

    K Number: K771574 · Decision Dec 6, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    47
    Applicant Total
    2
    Review Days
    113

    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
    LEE ASPIRATION NEEDLE
    K Number
    K771574
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Radiation Development Co., Inc.
    Date Received
    August 15, 1977
    Decision Date
    December 6, 1977
    Product Code
    GDM
    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
    GDM Needle, Aspiration And Injection, Reusable

    Similar 510(k) Clearances

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

    MARROWMINER

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

    BIOACCESS MARROW HARVEST SYSTEM

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

    ILIAC CREST BONE MARROW ASPIRATION NEEDLE

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

    BIOACCESS MARROW HARVEST SYSTEM

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

    ENDO-NEEDLE INSTRUMENT

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

    ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE

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

    Other Clearances by Radiation Development Co., Inc.

    K Number Device Name
    K772293 BONE MARROW BIOPSY DEVICE