Over-tube (TR-1108A)
K-Number: K243091 · 2024-11-01
ApplicantFujifilm Corporation
Decision Date2024-11-01
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Over-tube (TR-1108A) is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2024-11-01 under approval number K243091. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Over-tube (TR-1108A)?
Over-tube (TR-1108A) is a medical device that received FDA 510(k) clearance on 2024-11-01. It is manufactured by Fujifilm Corporation. The 510(k) number is K243091.
When was Over-tube (TR-1108A) approved by the FDA?
Over-tube (TR-1108A) received FDA 510(k) clearance on 2024-11-01, under approval number K243091.
What company makes Over-tube (TR-1108A)?
Over-tube (TR-1108A) is manufactured by Fujifilm Corporation.
What is the FDA product code for Over-tube (TR-1108A)?
The FDA product code for Over-tube (TR-1108A) is FED.
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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.