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

    ES-3840, VIDEO SIGMOIDOSCOPE

    K Number: K961567 · Decision Jun 24, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    23
    Applicant Total
    67
    Review Days
    62

    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
    ES-3840, VIDEO SIGMOIDOSCOPE
    K Number
    K961567
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pentax Precision Instrument Corp.
    Date Received
    April 23, 1996
    Decision Date
    June 24, 1996
    Product Code
    FAM
    Advisory Committee
    Gastroenterology, Urology
    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
    FAM Sigmoidoscope And Accessories, Flexible/Rigid

    Similar 510(k) Clearances

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

    ENDOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VS-100 VIDEO SIGMOIDOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ES-3800, VIDEO SIGMOIDOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Pentax Precision Instrument Corp.

    K Number Device Name
    K041396 FG-36UX FIBER ULTRASOUND GASTROSCOPE
    K041395 EG-3630UR
    K041397 EG-3830UT
    K031789 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    K023401 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    K023376 EB-1830T3, VIDEO BRONCHOSCOPE
    K021276 FG-36UX FIBER ULTRASOUND GASTROSCOPE
    K021278 EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
    K013640 EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
    K010740 FG-36UX, FIBER ULTRASOUND GASTROSCOPE
    Search all 67 clearances from Pentax Precision Instrument Corp. →