Fujifilm Duodenoscope Model ED-530XT
K-Number: K152257 · 2017-07-21
ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2017-07-21
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Fujifilm Duodenoscope Model ED-530XT is a medical device manufactured by Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-07-21 under approval number K152257. 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-530XT?
Fujifilm Duodenoscope Model ED-530XT is a medical device that received FDA 510(k) clearance on 2017-07-21. It is manufactured by Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K152257.
When was Fujifilm Duodenoscope Model ED-530XT approved by the FDA?
Fujifilm Duodenoscope Model ED-530XT received FDA 510(k) clearance on 2017-07-21, under approval number K152257.
What company makes Fujifilm Duodenoscope Model ED-530XT?
Fujifilm Duodenoscope Model ED-530XT is manufactured by Fujifilm Medical Systems U.S.A, Inc..
What is the FDA product code for Fujifilm Duodenoscope Model ED-530XT?
The FDA product code for Fujifilm Duodenoscope Model ED-530XT 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.