Device product
Video Cystoscope models ECY-1570 and ECY-1570K
Z-0615-2018
Product summary
- Event
- Event 79131
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24
- Official record key
device-enforcement:Z-0615-2018
Official wording
Reason: The video cytoscopes lack 510(k) premarket notification clearance.
Code information: 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
Distribution pattern: Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.
Derived failure modes
-
Unknown
The video cytoscopes lack 510(k) premarket notification clearance.