DeviceClearance

Product code FFL— Gastroenterology, Urology

METAL URETERAL BASKET STONE DISLODGER

Classification name
Dislodger, Stone, Basket, Ureteral, Metal
Device class
Class 2
Regulation
21 CFR 876.4680
Advisory panel
Gastroenterology, Urology
Total cleared
52
First cleared
Most recent

Market context for product code FFL

FDA has cleared 52 devices under product code FFL between 1979 and 2019, filed by 30 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 FFL

Adverse events under product code FFL

product code FFL
Death
2
Injury
270
Malfunction
2,711
Other
2
Total
2,985

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 FFL

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