Automatic Micro Needle System (CODE-X)— 510(k) K252591

Name: FDA 510(k) clearance K252591
Creator: U.S. Food and Drug Administration
Published: 2026-05-13

Substantially Equivalent

Woorhi Mechatronics Co., Ltd.

FDA 510(k) clearance K252591 for Automatic Micro Needle System (CODE-X), Substantially Equivalent on 2026-05-13. Applicant: Woorhi Mechatronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Woorhi Mechatronics Co., Ltd.
Product code: Code QAI
Device class: Class 2
Regulation: 21 CFR 878.4430
Advisory panel: General, Plastic Surgery
Date received: 2025-08-15
Decision date: 2026-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gunpo-Si, KR

Download summary PDF View on FDA.gov ↗

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