Blue Eye (TS-905)— 510(k) K220434

Substantially Equivalent

The Standard Co., Ltd.

FDA 510(k) clearance K220434 for Blue Eye (TS-905), Substantially Equivalent on 2022-08-12. 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: 2022-02-15
Decision date: 2022-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gunpo-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLL

K260997 — SIS BLU (SISBLU-30-01); SIS BLU (SISBLU-15-01)2026-09-09
K241591 — Blue Eye2024-07-03
K221385 — LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)2022-08-11
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.