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

    NEURAY SURGICAL PATTIES AND STRIPS

    K Number: K923027 · Decision Aug 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    66

    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
    NEURAY SURGICAL PATTIES AND STRIPS
    K Number
    K923027
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4700
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Martland Healthcare, Inc.
    Date Received
    June 23, 1992
    Decision Date
    August 28, 1992
    Product Code
    HBA
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HBA Neurosurgical Paddie

    Similar 510(k) Clearances

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

    Codman Surgical Patties & Strips

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDLINE NEURO SPONGE

    FDA 510(k)
    FDA Class 2 ·Neurology

    AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DELICOT

    FDA 510(k)
    FDA Class 2 ·Neurology

    NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES

    FDA 510(k)
    FDA Class 2 ·Neurology

    AESCULAP NEURO PATTIES

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all