This device is classified as import for export, therefore 510k is not applicable.There is a similar model eg38-j10ut-us available for sale in the united states with a 510k #k200090.The device was returned to pentax for further evaluation on service order (b)(4) where its currently pending investigation.If additional information becomes available, a supplemental report will be filed with the new information.
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Pentax medical was made aware of an event which occurred in the pai region involving pentax endoscope model eg38-j10ut.In the event reported, the user stated that the device have insufflation malfunction.The event timing is in the procedure room during use.There was no adverse event reported with this complaint.No other information provided with this complaint.This event meets the requirement for fda reportability; therefore, submission of a report does not constitute an admission that medical personnel, user facility, importer, manufacturer, or product caused or contributed to the event.
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