FDA-Device2018-02-21Class II
Video Cystoscope models ECY-1570 and ECY-1570K
Pentax of America Inc
Hazard
The video cytoscopes lack 510(k) premarket notification clearance.
Sold states
Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.
Affected count
24
Manufactured in
3 Paragon Dr, Montvale, NJ, United States
Products
Video Cystoscope models ECY-1570 and ECY-1570K
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0615-2018Don't want to check this manually?
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