DeviceClearance

Product code FDI— Gastroenterology, Urology

Polypectomy Snare

Classification name
Snare, Flexible
Device class
Class 2
Regulation
21 CFR 876.4300
Advisory panel
Gastroenterology, Urology
Total cleared
63
First cleared
Most recent

Market context for product code FDI

FDA has cleared 63 devices under product code FDI between 1985 and 2026, filed by 40 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 FDI

Adverse events under product code FDI

product code FDI
Death
6
Injury
217
Malfunction
1,544
Total
1,767

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 FDI

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