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 Steris, Promisemed Hangzhou Meditech Co., Ltd. and Olympus Medical Systems Corporation.
List of Endoscopic Injection Needle, Gastroenterology-urology devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Endoscopic Injection Needle, Gastroenterology-urology devices (product code FBK). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →