Over-tube (3 models)— 510(k) K230752

Name: FDA 510(k) clearance K230752
Creator: U.S. Food and Drug Administration
Published: 2023-09-15

Substantially Equivalent

FUJIFILM Healthcare Americas Corporation

FDA 510(k) clearance K230752 for Over-tube (3 models), Substantially Equivalent on 2023-09-15. Applicant: FUJIFILM Healthcare Americas Corporation. Device class: 2.

Clearance details

Device name as filed: Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)
Applicant: FUJIFILM Healthcare Americas Corporation
Product code: Code FED
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-03-17
Decision date: 2023-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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K252572 — Prodeon Urethral Sheath System2025-10-07

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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.