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

    SKIN BIOPSY DEVICE

    K Number: K933324 · Decision Mar 31, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    262

    Basic Information

    Device Name
    SKIN BIOPSY DEVICE
    K Number
    K933324
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    NHR, INC.
    Date Received
    July 12, 1993
    Decision Date
    March 31, 1994
    Product Code
    MJG
    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
    MJG Device, Percutaneous, Biopsy

    Similar 510(k) Clearances

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

    PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM

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

    EXICLIP EXCS-M

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

    ECHO-COAT ULTRASOUND NEEDLES

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

    RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY

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

    SPACER

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

    DYNACYT BIOPSY ASPIRATION DEVICE

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