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

    LAGIS ENDOSCOPIC INSTRUMENTS

    K Number: K090309 · Decision Aug 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    839
    Registration Numbers
    839
    Same Product Code
    2251
    Applicant Total
    2
    Review Days
    203

    Basic Information

    Device Name
    LAGIS ENDOSCOPIC INSTRUMENTS
    K Number
    K090309
    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
    LAGIS ENTERPRISES CO, LTD.
    Date Received
    February 6, 2009
    Decision Date
    August 28, 2009
    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 LAGIS ENTERPRISES CO, LTD.

    K Number Device Name
    K141902 LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER