Cleared Traditional

EverLift Submucosal Lifting Agent

K191923 · Gi Supply · Gastroenterology & Urology

Jun 2020

Decision

338d

Days

Class 2

Risk

About This 510(k) Submission

K191923 is an FDA 510(k) clearance for the EverLift Submucosal Lifting Agent, a Submucosal Injection Agent (Class II — Special Controls, product code PLL), submitted by Gi Supply (Mechanicsburg, US). The FDA issued a Cleared decision on June 20, 2020, 338 days after receiving the submission on July 18, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K191923 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 2019
Decision Date	June 20, 2020
Days to Decision	338 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	PLL — Submucosal Injection Agent
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
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.