DeviceClearance

Product code FFT— Gastroenterology, Urology

PROXIMA 1 PH MONITOR

Classification name
Electrode, Ph, Stomach
Device class
Class 1
Regulation
21 CFR 876.1400
Advisory panel
Gastroenterology, Urology
Total cleared
49
First cleared
Most recent

Market context for product code FFT

FDA has cleared 49 devices under product code FFT between 1981 and 2010, filed by 28 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code FFT

Adverse events under product code FFT

product code FFT
Injury
595
Malfunction
2,175
Other
1
Total
2,771

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 FFT

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