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

    Hawkeye Control Unit with Eyas Endoscope

    K Number: K233115 · Decision Feb 6, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    5
    Review Days
    132

    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
    Hawkeye Control Unit with Eyas Endoscope
    K Number
    K233115
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    E Surgical, LLC
    Date Received
    September 27, 2023
    Decision Date
    February 6, 2024
    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

    Similar 510(k) Clearances

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

    Digital ClarusScope System and Digital NeuroPEN System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Freedom DS™ Decompression System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VantageTM Lumbar Decompression Kit

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PUREVUE™ FMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Articulator Arthroscopic Bur

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by E Surgical, LLC

    K Number Device Name
    K231126 Eblator Device
    K071080 ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M
    K061878 ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC
    K060255 E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE