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

    BURS FOR MICRO SURGICAL DRILL SYSTEM

    K Number: K853658 · Decision Sep 24, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    15
    Applicant Total
    8
    Review Days
    21

    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
    BURS FOR MICRO SURGICAL DRILL SYSTEM
    K Number
    K853658
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Acumed Instruments Corp.
    Date Received
    September 3, 1985
    Decision Date
    September 24, 1985
    Product Code
    GFF
    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
    GFF Bur, Surgical, General & Plastic Surgery

    Similar 510(k) Clearances

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

    ANSPACH SHIELDED ATTACHMENT

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

    SURGICAL BUR

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

    SURGICAL BUR

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

    BURRS

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

    MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS

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

    DANEK IRRIGATING BURR (DIB) SET

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

    Other Clearances by Acumed Instruments Corp.

    K Number Device Name
    K863627 MICRO SURGICAL DRILL SYSTEM
    K853660 MICRO SURGICAL DRILL SYSTEM
    K853659 POWERED IRRIGATION FOR MICRO SURGICAL DRILL
    K791891 ACU-MED RED MISER HEMOTHORAX BLOOD COLL.
    K791399 ACU-ALERT
    K791400 GASTRIC LAVAGE KIT-DISPOSABLE
    K790901 I.V. TUBING ORGANIZER