Device type

Submucosal Injection Agent

Product code PLL · Class II · 21 CFR 876.1500 · Gastroenterology, Urology

Intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.

FDA classification database