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

    G210 InviCell Plus with SignipHy pH monitoring

    K Number: K191020 · Decision Jan 14, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    0
    Applicant Total
    41
    Review Days
    272

    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
    G210 InviCell Plus with SignipHy pH monitoring
    K Number
    K191020
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6120
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CooperSurgical, Inc.
    Date Received
    April 17, 2019
    Decision Date
    January 14, 2020
    Product Code
    PUB
    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
    PUB Accessory, Assisted Reproduction, Exempt

    Other Clearances by CooperSurgical, Inc.

    K Number Device Name
    K243799 Fetal Pillow
    K250438 CooperSurgical Milex® Pessaries
    K223064 ALLY II Uterine Positioning System™ (UPS)
    K201086 Advincula Delineator Uterine Manipulator
    K200038 Endosee System
    K191291 Wallace Dual Lumen Oocyte Recovery System
    K190639 Endosee System
    K182959 Wallace Dual Lumen Oocyte Recovery System
    K183020 Endosee System
    K180429 Advincula Delineator Uterine Manipulator
    Search all 41 clearances from CooperSurgical, Inc. →