Cleared Special

Blue Eye

K241591 · The Standard Co., Ltd. · Gastroenterology & Urology

Jul 2024

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K241591 is an FDA 510(k) clearance for the Blue Eye, a Submucosal Injection Agent (Class II — Special Controls, product code PLL), submitted by The Standard Co., Ltd. (Gunpo-Si, KR). The FDA issued a Cleared decision on July 3, 2024, 30 days after receiving the submission on June 3, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K241591 FDA.gov
FDA Decision	Cleared 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

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.