BEUDAMED
    Product Code: GFI FDA class 1 21 CFR 878.4800

    Osteotome, Manual

    General, Plastic Surgery

    The Osteotome, Manual (product code GFI) is a handheld chisel-like surgical instrument used to cut or shape bone during general and plastic surgery procedures, typically struck with a mallet to create controlled osteotomies or fractures. It is classified as an FDA Class 1 device, the lowest risk category, subject to general controls only and not requiring premarket notification. Regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU), this device carries no special regulatory flags.

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    510(k)s
    6
    FEI Numbers
    142
    Registration Numbers
    142
    Unique Applicants
    6
    Years Active
    9

    Basic Information

    Product Code
    GFI
    Device Class
    FDA class 1
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 6 510(k) clearances via K numbers.

    K Number Device Name
    K933181 VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500
    K932534 ISI FENESTRATED DISSECTING AND GRASPING FORCEPS
    K920001 HEMOLAB SILIMAT REAGENT
    K891887 OSTEOTOMES, VARIOUS TYPES
    K852541 STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS
    K842823 CHERMEL OSTEOTOMES

    FEI Numbers

    This FDA classification entry is associated with 142 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 142 registration numbers. Click on an entry to view related FDA registrations.