This model is classified as import for export and not distributed in the united states, therefore 510k is not applicable.We do have similar model eg38-j10ut-us available in the united states with a 510k number k200090.(b)(4).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 a complaint which occurred in the emea region reporting "the ift is loosened and leaky" involving pentax medical ultrasound video gastroscope model eg38-j10ut, serial number (b)(4).The event was reported to occur in the workshop, during inspection.There was no report of death, serious injury or other significant/important medical event.The ift must be fastened as part of the service request.This event is fda reportable due to the lack of information to justify that this event would not cause or contribute to a serious injury or other adverse event.
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