DeviceClearance

Product code FFX— Gastroenterology, Urology

SITZMARKS

Classification name
System, Gastrointestinal Motility (Electrical)
Device class
Class 2
Regulation
21 CFR 876.1725
Advisory panel
Gastroenterology, Urology
Total cleared
69
First cleared
Most recent

Market context for product code FFX

FDA has cleared 69 devices under product code FFX between 1976 and 2025, filed by 36 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 FFX

Adverse events under product code FFX

product code FFX
Other
1
Total
1

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 FFX

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