Blue Eye— 510(k) K241591

Substantially Equivalent

The Standard Co., Ltd.

FDA 510(k) clearance K241591 for Blue Eye, Substantially Equivalent on 2024-07-03. Applicant: The Standard Co., Ltd.. Device class: 2.

Clearance details

Applicant: The Standard Co., Ltd.
Product code: Code PLL
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2024-06-03
Decision date: 2024-07-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Gunpo-Si, KR

Download summary PDF View on FDA.gov ↗

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K200071 — Blue Beacon Submucosal Injectable Solution2020-11-03
K202376 — EverLift Submucosal Lifting Agent2020-09-30

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