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

    Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019

    K Number: K230255 · Decision Mar 28, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    32
    Review Days
    56

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    Basic Information

    Device Name
    Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019
    K Number
    K230255
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Sustainability Solutions
    Date Received
    January 31, 2023
    Decision Date
    March 28, 2023
    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

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    K241606 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)
    K233471 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)
    K231621 Reprocessed ViewFlex Xtra ICE Catheter (D087031)
    K230251 Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
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    K220481 Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)
    K220411 Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
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