FDA-Device2016-07-06Class II
Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Bladder. The instrument is introduced via the urethra when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Pentax Medical Company
Hazard
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Sold states
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
Affected count
120 units
Manufactured in
3 Paragon Dr, Montvale, NJ, United States
Products
Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Bladder. The instrument is introduced via the urethra when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2070-2016Don't want to check this manually?
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