DeviceClearance

Product code FDF— Gastroenterology, Urology

G-EYE System

Classification name
Colonoscope And Accessories, Flexible/Rigid
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
114
First cleared
Most recent

FDA classification definition

“To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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 FDF under 21 CFR 876.1500, via openFDA

Market context for product code FDF

FDA has cleared 114 devices under product code FDF between 1976 and 2026, filed by 53 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 FDF

Adverse events under product code FDF

product code FDF
Death
8
Injury
729
Malfunction
61,773
Total
62,510

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 FDF

1–100 of 114

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