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

    ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE

    K Number: K090084 · Decision Mar 6, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    178
    Review Days
    53

    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
    ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE
    K Number
    K090084
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merit Medical Systems, Inc.
    Date Received
    January 12, 2009
    Decision Date
    March 6, 2009
    Product Code
    GEX
    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
    GEX Powered Laser Surgical Instrument

    Similar 510(k) Clearances

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

    Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)

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

    PICOSURE WORKSTATION

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

    LumiGlam Laser System (SHE-LSP601-3)

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

    LASEmaR 1500

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

    LUNE PureHygiene

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

    Boston 2910 (Boston 2910)

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

    Other Clearances by Merit Medical Systems, Inc.

    K Number Device Name
    K254073 StatSeal Disc
    K251802 STAR RF Ablation System
    K252892 SCOUT MD Surgical Guidance System
    K250853 Merit Syringe
    K251265 Resilience Fully Covered Esophageal Stent System
    K250909 Prelude Wave Hydrophilic Sheath Introducer
    K242873 Ventrax™ Delivery System
    K242229 Micro Ace Gold Advanced Micro Access System
    K241521 Prelude Small O.D. Introducer Guide Wire
    K233268 Impress Angiographic Catheter
    Search all 178 clearances from Merit Medical Systems, Inc. →