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

    CRANIO BLADES AND WIRE PASS DRILL

    K Number: K861876 · Decision May 30, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    304
    Registration Numbers
    304
    Same Product Code
    26
    Applicant Total
    18
    Review Days
    15

    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
    CRANIO BLADES AND WIRE PASS DRILL
    K Number
    K861876
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    New England Surgical Instrument Corp.
    Date Received
    May 15, 1986
    Decision Date
    May 30, 1986
    Product Code
    GFA
    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
    GFA Blade, Saw, General & Plastic Surgery, Surgical

    Similar 510(k) Clearances

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

    GRAFT HARVESTING SAWBLADES

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

    STRYKER SAGITTAL SAW ATTACHMENT

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

    WRIGHT MEDICAL TECHNOLOGY SAWBLADES

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

    DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS

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

    SURGICAL SAW BLADES

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

    RE-SHARPENABLE SAW BLADES

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

    Other Clearances by New England Surgical Instrument Corp.

    K Number Device Name
    K895337 ELECTROSURGICAL COAGULATION SUCTION TUBE
    K895331 ELECTROSURGICAL ELECTRODE
    K883963 RANEY AND LEROY-RANEY SCALP CLIP
    K883396 HANDSWITCHING MONOPOLAR PENCIL
    K880863 BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200
    K880859 SURGICAL BURS
    K872271 VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS
    K872209 ARTHROPLASTY MALLET
    K864770 SUCTION TUBE
    K864775 CHISEL (OSTEOTOME, GOUGE, ETC.)
    Search all 18 clearances from New England Surgical Instrument Corp. →