DeviceClearance

Product code FGB— Gastroenterology, Urology

Medical Video Endoscope System

Classification name
Ureteroscope And Accessories, Flexible/Rigid
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
118
First cleared
Most recent

FDA classification definition

“To perform various diagnostic and therapeutic procedures within the urinary tract. 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 FGB under 21 CFR 876.1500, via openFDA

Market context for product code FGB

FDA has cleared 118 devices under product code FGB between 1981 and 2026, filed by 63 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 FGB

Adverse events under product code FGB

product code FGB
Death
6
Injury
552
Malfunction
3,922
Other
1
Total
4,481

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 FGB

1–100 of 118

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