Submucosal Injection Agent

What Is This Device?

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.

What Is FDA Product Code PLL?

Submucosal Injection Agent is FDA product code PLL, Class 2, 21 CFR 876.1500.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 2 clearances under this code; the FDA took a median of 280 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2022. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.