Cleared Traditional

EverLift Submucosal Lifting Agent (K191923) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191923 · Gi Supply · Gastroenterology & Urology device
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Jun 2020
Decision
338d
Days
Class 2
Risk

K191923 is an FDA 510(k) clearance for the EverLift Submucosal Lifting Agent. Classified as Submucosal Injection Agent (product code PLL), Class II - Special Controls.

Submitted by Gi Supply (Mechanicsburg, US). The FDA issued a Cleared decision on June 20, 2020 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K191923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 130d · This submission: 338d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PLL Submucosal Injection Agent
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PLL Submucosal Injection Agent

All 8
Devices cleared under the same product code (PLL) and FDA review panel - the closest regulatory comparables to K191923.
Blue Eye
K241591 · The Standard Co., Ltd. · Jul 2024
Blue Eye (TS-905)
K220434 · The Standard Co., Ltd. · Aug 2022
LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
K221385 · Ovesco Endoscopy AG · Aug 2022
Blue Beacon Submucosal Injectable Solution
K200071 · Micro-Tech (Nanjing) Co., Ltd. · Nov 2020
EverLift Submucosal Lifting Agent
K202376 · Gi Supply, Inc. · Sep 2020
EndoClot
K191254 · Endoclot Plus Co., Ltd. · Jan 2020