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

    AED Sinuscope

    K Number: K170285 · Decision Aug 1, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    161
    Applicant Total
    8
    Review Days
    183

    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
    AED Sinuscope
    K Number
    K170285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4760
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    National Advanced Endoscopy Devices, Inc.
    Date Received
    January 30, 2017
    Decision Date
    August 1, 2017
    Product Code
    EOB
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EOB Nasopharyngoscope (Flexible Or Rigid)

    Similar 510(k) Clearances

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

    Hydro Irrigation System

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ENTity USB Videoscope System

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Outlook Surgical Versa One System (8900139)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Portare System (FA-001)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by National Advanced Endoscopy Devices, Inc.

    K Number Device Name
    K141515 AED HYSTEROSCOPE AND ACCESSORIES
    K102663 AED RESECTOSCOPE
    K081553 AED BIPOLAR FORCEPS, MODEL 13-1646
    K081503 AED MONOPOLAR LAP ACCESSORIES
    K993689 AED CYSTOSCOPE
    K993688 AED LAPAROSCOPE
    K991656 AED ARTHROSCOPE