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.

Summary

Woorhi Mechatronics filed the Automatic Micro Needle System (CODE-X) under QAI, powered microneedle devices.

Class II, 21 CFR 878.4430. General and Plastic Surgery is both the classification panel and the review panel, and it was a Traditional 510(k).

Woorhi filed from Gunpo-Si, South Korea. The decision came 271 calendar days after receipt (August 15, 2025 to May 13, 2026).

Clearance details

Applicant: Woorhi Mechatronics Co., Ltd.
Product code: Product 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.