FDA Product Code FBK: Endoscopic Injection Needle, Gastroenterology-urology

Endoscopic injection enables precise delivery of agents to gastrointestinal lesions. FDA product code FBK covers endoscopic injection needles for gastrointestinal use.

These retractable needle devices are passed through the working channel of an endoscope to inject hemostatic agents, sclerosants, submucosal lifting solutions, and chemotherapeutic agents directly at target sites within the gastrointestinal tract.

FBK devices are Class II medical devices, regulated under 21 CFR 876.1500 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Carbon Medical Technologies, Inc., Wilson-Cook Medical, Inc. and Boston Scientific Corp.