DeviceClearance

Product code FJI— Gastroenterology, Urology

CAPILLARY FLOW DIALYZERS

Classification name
Dialyzer, Capillary, Hollow Fiber
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Total cleared
131
First cleared
Most recent

Market context for product code FJI

FDA has cleared 131 devices under product code FJI between 1976 and 2019, filed by 42 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 FJI

Adverse events under product code FJI

product code FJI
Death
2
Total
2

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 FJI

1–100 of 131

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