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

    OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE

    K Number: K982733 · Decision Oct 28, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    22
    Review Days
    84

    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
    OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE
    K Number
    K982733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Olympus Optical Co.
    Date Received
    August 5, 1998
    Decision Date
    October 28, 1998
    Product Code
    ITX
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ITX Transducer, Ultrasonic, Diagnostic

    Similar 510(k) Clearances

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

    ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mendaera Guidance System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Accuro® 3S Needle Guide Kit

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ultrasound Transducer Cover

    FDA 510(k)
    FDA Class 2 ·Radiology

    UltraDrape UGPIV Barrier and Securement (34-15)

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

    Other Clearances by The Olympus Optical Co.

    K Number Device Name
    K032066 SONOSURG SYSTEM
    K030194 XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
    K021962 OLYMPUS ULTRASONIC SURGICAL SYSTEM
    K023984 MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES
    K023272 DISPOSABLE ASPIRATION NEEDLE NA-200H
    K023767 UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES
    K012074 XBO1-824-18/19/20 BIOPSY FORCEPS
    K012073 OLYMPUS SPRAY CATHETER PW-6C-1
    K011869 XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
    K011149 DISPOSABLE BENDING CANNULA PR-233Q
    Search all 22 clearances from The Olympus Optical Co. →