FDA-Device2016-08-03Class II
Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Pentax Medical Company
Hazard
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
Sold states
US Nationwide Distribution
Affected count
10,074 units
Manufactured in
3 Paragon Dr, N/A, Montvale, NJ, United States
Products
Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth 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-2278-2016Don't want to check this manually?
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