Over-tube (TR-1108A)— 510(k) K243091

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K243091 for Over-tube (TR-1108A), Substantially Equivalent on 2024-11-01. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2024-09-30
Decision date: 2024-11-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FED

product code FED

Death: 10
Total: 10

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.