BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HYPODERMIC NEEDLE SHEATH HOLDER

    K Number: K882405 · Decision Jun 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    19

    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
    HYPODERMIC NEEDLE SHEATH HOLDER
    K Number
    K882405
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2500
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Ansr Ent., Inc.
    Date Received
    June 10, 1988
    Decision Date
    June 29, 1988
    Product Code
    FMJ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMJ Manometer, Spinal-Fluid

    Similar 510(k) Clearances

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

    Spinal Manometer NRFit; Spinal Manometer LUER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LUMBAR PUNCTURE KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEGA LUMBAR PUNCTURE KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all