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510(k) K243091

Over-tube (TR-1108A) by Fujifilm Corporation — Product Code FED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2024
Date Received
September 30, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

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