FUJIFILM Duodenoscope Model ED-580XT
K-Number: K191747 · 2019-09-27
ApplicantFujifilm Corporation
Decision Date2019-09-27
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
FUJIFILM Duodenoscope Model ED-580XT is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2019-09-27 under approval number K191747. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FUJIFILM Duodenoscope Model ED-580XT?
FUJIFILM Duodenoscope Model ED-580XT is a medical device that received FDA 510(k) clearance on 2019-09-27. It is manufactured by Fujifilm Corporation. The 510(k) number is K191747.
When was FUJIFILM Duodenoscope Model ED-580XT approved by the FDA?
FUJIFILM Duodenoscope Model ED-580XT received FDA 510(k) clearance on 2019-09-27, under approval number K191747.
What company makes FUJIFILM Duodenoscope Model ED-580XT?
FUJIFILM Duodenoscope Model ED-580XT is manufactured by Fujifilm Corporation.
What is the FDA product code for FUJIFILM Duodenoscope Model ED-580XT?
The FDA product code for FUJIFILM Duodenoscope Model ED-580XT is FDT.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.