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

    BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE

    K Number: K112233 · Decision Jan 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    839
    Registration Numbers
    839
    Same Product Code
    2251
    Applicant Total
    10
    Review Days
    176

    Basic Information

    Device Name
    BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE
    K Number
    K112233
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BOVIE MEDICAL CORPORATION
    Date Received
    August 4, 2011
    Decision Date
    January 27, 2012
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    Similar 510(k) Clearances

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

    DENSITY; DENZA; DENSITY Noir

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HybridAPC probe

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Electrosurgical Pads

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EndyMed PRO MAX

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DELPHI System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    gi2000 Electrosurgical Generator

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by BOVIE MEDICAL CORPORATION

    K Number Device Name
    K161558 Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating
    K161134 Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator
    K152777 Bovie Disposable Bipolar Ablator
    K152570 Bovie J-Plasma Precise 360 Handpiece
    K151325 Bovie J-Plasma Handpiece
    K134054 BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
    K121441 CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)
    K092383 BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300
    K093025 BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES