Pentax

  • Model / Serial
    Model #'s FD-34V and ED-3490TK
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Duodenoscope || Product Usage: || Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Pentax Medical Company, 3 Paragon Dr, Montvale NJ 07645-1782
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

143 devices with a similar name

Learn more about the data here

  • Model / Serial
    EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970, EB-1970AK,
  • Product Description
    These instruments are intended to provide an ultrasonic and optical visualization of the pulmonary tracts (through a video monitor), for therapeutic access of the pulmonary tract. Which includes (without limitation) organs, tissues and subsystems, in addition to the trachea and bronchial tree beyond the stem. Endoscopy for visualization of organs and body cavities of the lower respiratory system.
  • Manufacturer
  • Model / Serial
  • Product Description
    (1) - (4) Video soft bronchoscope (5) - (6) Video soft cystoscope (7) Video soft hysteroscope 70141000 (8) - (9) Video flexible nasopharyngeal mirror
  • Manufacturer
  • Model / Serial
  • Product Description
    Video flexible duodenoscope
  • Manufacturer
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