DeviceClearance

Product code FCF— Gastroenterology, Urology

AMCATH DISPOSABLE BIOPSY FORCEPS

Classification name
Instrument, Biopsy, Mechanical, Gastrointestinal
Device class
Class 2
Regulation
21 CFR 876.1075
Advisory panel
Gastroenterology, Urology
Total cleared
6
First cleared
Most recent

Market context for product code FCF

FDA has cleared 6 devices under product code FCF between 1984 and 2007, filed by 5 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

Top applicants under product code FCF

Recent clearances under product code FCF

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