Recall Z-0615-2018— Pentax of America Inc
Class II · Terminated
Class II FDA medical device recall by Pentax of America Inc, initiated 2017-07-13, terminated 2019-07-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Video Cystoscope models ECY-1570 and ECY-1570K. Reason: The video cytoscopes lack 510(k) premarket notification clearance..
- Recalling firm
- Pentax of America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-13
- Terminated
- 2019-07-22
- Firm location
- Montvale, NJ, United States
Product description
Video Cystoscope models ECY-1570 and ECY-1570K
Reason for recall
The video cytoscopes lack 510(k) premarket notification clearance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.