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

    Aurora Evacuator +Coag

    K Number: K201637 · Decision Aug 12, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    6
    Review Days
    57

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    Basic Information

    Device Name
    Aurora Evacuator +Coag
    K Number
    K201637
    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
    Rebound Therapeutics
    Date Received
    June 16, 2020
    Decision Date
    August 12, 2020
    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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    Other Clearances by Rebound Therapeutics

    K Number Device Name
    K203745 AURORA Evacuator +Coag
    K201840 Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
    K191861 Aurora Surgiscope System
    K190075 Aurora Evacuator
    K180372 Aurora Evacuator