Cleared Special

Blue Eye (K241591) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K241591 · The Standard Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
30d
Days
Class 2
Risk

K241591 is an FDA 510(k) clearance for the Blue Eye. Classified as Submucosal Injection Agent (product code PLL), Class II - Special Controls.

Submitted by The Standard Co., Ltd. (Gunpo-Si, KR). The FDA issued a Cleared decision on July 3, 2024 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all The Standard Co., Ltd. devices

Submission Details

510(k) Number K241591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2024
Decision Date July 03, 2024
Days to Decision 30 days
Submission Type Special
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
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

LK Consulting Group USA, Inc.
Priscilla Chung

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PLL Submucosal Injection Agent

All 7
Devices cleared under the same product code (PLL) and FDA review panel - the closest regulatory comparables to K241591.
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
EverLift Submucosal Lifting Agent
K191923 · Gi Supply · Jun 2020
EndoClot
K191254 · Endoclot Plus Co., Ltd. · Jan 2020