DeviceClearance

Product code FDT— Gastroenterology, Urology

Evis Exera III Duodenovideoscope Olympus TJF-Q190V

Classification name
Duodenoscope And Accessories, Flexible/Rigid
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
35
First cleared
Most recent

FDA classification definition

“To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).”

— U.S. Food and Drug Administration, device classification record for product code FDT under 21 CFR 876.1500, via openFDA

Market context for product code FDT

FDA has cleared 35 devices under product code FDT between 1983 and 2026, filed by 16 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code FDT

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 →

Recent clearances under product code FDT

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