DeviceClearance

Product code FBN— Gastroenterology, Urology

FLEXIBLE CHOLEDOCHOSCOPE

Classification name
Choledochoscope And Accessories, Flexible/Rigid
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
43
First cleared
Most recent

FDA classification definition

“to examine and perform procedures within the bile ducts. 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 FBN under 21 CFR 876.1500, via openFDA

Market context for product code FBN

FDA has cleared 43 devices under product code FBN between 1977 and 2026, filed by 26 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 FBN

Adverse events under product code FBN

product code FBN
Death
8
Malfunction
951
Total
959

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 FBN

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