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

    EndoRotor

    K Number: K170120 · Decision Apr 18, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    4
    Review Days
    95

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    Basic Information

    Device Name
    EndoRotor
    K Number
    K170120
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Interscope, Inc.
    Date Received
    January 13, 2017
    Decision Date
    April 18, 2017
    Product Code
    PTE
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PTE Endoscopic Morcellator Gastroenterology

    Similar 510(k) Clearances

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

    EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
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    Other Clearances by Interscope, Inc.

    K Number Device Name
    DEN200016 EndoRotor Device
    K190715 EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand
    K181127 EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control