Devices

Device Recall Video Cystoscope models ECY1570 and ECY1570K

  • Model / Serial
    Serial number: J110097 J110101 G110053 G110051 G110052 G110054 G110015 G110084 H110086 H110088 J110062 G110016 G110039 G110048 G110049 G110038 J110061 G110021 J110078 G110056 G110057 G110073 G110037 G110058
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.
  • Product Description
    Video Cystoscope models ECY-1570 and ECY-1570K
  • Manufacturer
    Pentax of America Inc
  • 1 Event

Manufacturer

Pentax of America Inc
  • Manufacturer Address
    Pentax of America Inc, 3 Paragon Dr, Montvale NJ 07645-1782
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    USFDA