DeviceClearance

Product code FCL— Gastroenterology, Urology

BIOPSY FORCEPS

Classification name
Forceps, Biopsy, Non-Electric
Device class
Class 1
Regulation
21 CFR 876.1075
Advisory panel
Gastroenterology, Urology
Total cleared
39
First cleared
Most recent

Market context for product code FCL

FDA has cleared 39 devices under product code FCL between 1980 and 2003, filed by 29 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

Top applicants under product code FCL

Adverse events under product code FCL

product code FCL
Death
5
Total
5

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 FCL

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