510(k) K243091
K243091 is an FDA 510(k) premarket notification submitted by Fujifilm Corporation for the device "Over-tube (TR-1108A)". The FDA issued a decision of Substantially Equivalent on November 1, 2024. The device falls under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Fujifilm Corporation has at least 10 other 510(k) clearances on record.
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.