DeviceClearance

Product code PLL— Gastroenterology, Urology

EverLift Submucosal Lifting Agent

Classification name
Submucosal Injection Agent
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
10
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code PLL under 21 CFR 876.1500, via openFDA

Market context for product code PLL

FDA has cleared 10 devices under product code PLL between 2015 and 2026, filed by 8 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 PLL

Recent clearances under product code PLL

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