FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM— 510(k) K040048

Name: FDA 510(k) clearance K040048
Creator: U.S. Food and Drug Administration
Published: 2004-06-07

Substantially Equivalent

Fujinon, Inc.

FDA 510(k) clearance K040048 for FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM, Substantially Equivalent on 2004-06-07. Applicant: Fujinon, Inc.. Device class: 2.

Clearance details

Applicant: Fujinon, Inc.
Product code: Product code FDA
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2004-01-12
Decision date: 2004-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntington, CT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FDA

product code FDA

Death: 8
Injury: 148
Total: 156

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.