BEUDAMED
    Product Code: GFA FDA class 1 21 CFR 878.4820

    Blade, Saw, General & Plastic Surgery, Surgical

    General, Plastic Surgery

    The Blade, Saw, General and Plastic Surgery, Surgical (product code GFA) is a cutting attachment used with powered surgical instrument systems to perform bone or tissue sawing during general and plastic surgery procedures. It is classified as an FDA Class 1 device, the lowest risk category, subject to general controls with no premarket notification required. Regulated under 21 CFR 878.4820 in the General, Plastic Surgery specialty (SU), this device has no special regulatory flags.

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    510(k)s
    27
    FEI Numbers
    299
    Registration Numbers
    299
    Unique Applicants
    21
    Years Active
    17

    Basic Information

    Product Code
    GFA
    Device Class
    FDA class 1
    Regulation Number
    878.4820
    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 27 510(k) clearances via K numbers.

    K Number Device Name
    K971978 GRAFT HARVESTING SAWBLADES
    K954483 STRYKER SAGITTAL SAW ATTACHMENT
    K955229 WRIGHT MEDICAL TECHNOLOGY SAWBLADES
    K953012 DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS
    K950403 SURGICAL SAW BLADES
    K940501 RE-SHARPENABLE SAW BLADES
    K933595 BUR, SURGICAL, GENERAL & PLASTIC SURGERY
    K935391 SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK
    K934603 SURGICAL SAW BLADES
    K931769 SNAP OSCILLATING SAW
    K934390 OSCILLATING BONE SAW BLADE, 6200 SERIES
    K931210 INTERMEDICS ORTHOPEDICS SAW BLADE
    K933298 SAW BLADE
    K924953 FLUID COOLED BONE SAW BLADE, 6000 SERIES
    K912761 SURGICAL SAW BLADES
    K896280 MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50
    K863788 SAWBLADE
    K861876 CRANIO BLADES AND WIRE PASS DRILL
    K854192 ANADIAS NASAL SAW BLADES
    K851880 BRIMFIELD SCIEN. INSTRU. DISPOS. STERILE SURG. BLA
    K831714 MICRO-AIRE REPLACEMENT SURG. SAW BLADE
    K830434 DISPOSABLE INTRA-ARTICULAR BLADE
    K821487 MICRO-SURGICAL POWER INSTRUMENT SYS.
    K820601 REPLACEMENT SAW BLADES FOR STRYKER AIR
    K811506 MICRO-AIRE REPLACEMENT SAW BLADES
    K810045 I.M. RETROGRADE BLADES
    K802838 STERNUM SAW BLADE

    FEI Numbers

    This FDA classification entry is associated with 299 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 299 registration numbers. Click on an entry to view related FDA registrations.