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

    HydroCision SpineJet System

    K Number: K200729 · Decision Apr 16, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    12
    Review Days
    27

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    Basic Information

    Device Name
    HydroCision SpineJet System
    K Number
    K200729
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hydrocision, Inc.
    Date Received
    March 20, 2020
    Decision Date
    April 16, 2020
    Product Code
    HRX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HRX Arthroscope

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    Other Clearances by Hydrocision, Inc.

    K Number Device Name
    K241990 SpineSite Endoscope System
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    K021813 HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM
    K020688 HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR
    K011612 MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM
    K002764 HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR
    K991383 HYDROCISION DEBDRIDEMENT SYSTEM
    K993009 HYDROCISION ARTHROJET SYSTEM WITH CAUTERY
    Search all 12 clearances from Hydrocision, Inc. →