DeviceClearance

Product code FED— Gastroenterology, Urology

Single-use Ureteral Access Sheath

Classification name
Endoscopic Access Overtube, Gastroenterology-Urology
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
103
First cleared
Most recent

FDA classification definition

“To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.”

— U.S. Food and Drug Administration, device classification record for product code FED under 21 CFR 876.1500, via openFDA

Market context for product code FED

FDA has cleared 103 devices under product code FED between 1981 and 2026, filed by 65 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 FED

Adverse events under product code FED

product code FED
Death
10
Total
10

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 FED

1–100 of 103

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