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

    THERMEDX FLUID MANAGMENT SYSTEM

    K Number: K133799 · Decision Jun 20, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    55
    Applicant Total
    5
    Review Days
    189

    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
    THERMEDX FLUID MANAGMENT SYSTEM
    K Number
    K133799
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermedx, LLC
    Date Received
    December 13, 2013
    Decision Date
    June 20, 2014
    Product Code
    HIG
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIG Insufflator, Hysteroscopic

    Similar 510(k) Clearances

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

    Asurys Fluid Management System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    X-FLO Fluid Management System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Endomat Select, IBS Shaver Software, License

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Endomat Select

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Fluent Fluid Management System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Thermedx, LLC

    K Number Device Name
    K210628 X-FLO Fluid Management System
    K172048 FluidSmart
    K102275 THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240
    K091939 THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000