FDA-Device2016-07-06Class II
Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum 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
1,596 units
Manufactured in
3 Paragon Dr, Montvale, NJ, United States
Products
Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum 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-2075-2016Don't want to check this manually?
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