FDA-Device2016-07-06Class II
Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the anatomy being accessed 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
17 units
Manufactured in
3 Paragon Dr, Montvale, NJ, United States
Products
Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the anatomy being accessed 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-2069-2016Don't want to check this manually?
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