DeviceClearance

FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5— 510(k) K042076

Substantially Equivalent

Fujinon, Inc.

FDA 510(k) clearance K042076 for FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5, Substantially Equivalent on 2004-11-18. Applicant: Fujinon, Inc.. Device class: 2.

Clearance details

Applicant
Fujinon, Inc.
Product code
Code FDT
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Huntington, CT, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FDT

product code FDT
Death
86
Injury
1,954
Malfunction
14,912
Total
16,952

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

Recalls naming K042076

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042076.

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