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FDA 510(k)

Automatic Micro Needle System (CODE-X)

K-Number: K252591 · 2026-05-13

ApplicantWoorhi Mechatronics Co., Ltd.
Decision Date2026-05-13
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Automatic Micro Needle System (CODE-X) is a medical device manufactured by Woorhi Mechatronics Co., Ltd.. It received FDA 510(k) clearance on 2026-05-13 under approval number K252591. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Automatic Micro Needle System (CODE-X)?

Automatic Micro Needle System (CODE-X) is a medical device that received FDA 510(k) clearance on 2026-05-13. It is manufactured by Woorhi Mechatronics Co., Ltd.. The 510(k) number is K252591.

When was Automatic Micro Needle System (CODE-X) approved by the FDA?

Automatic Micro Needle System (CODE-X) received FDA 510(k) clearance on 2026-05-13, under approval number K252591.

What company makes Automatic Micro Needle System (CODE-X)?

Automatic Micro Needle System (CODE-X) is manufactured by Woorhi Mechatronics Co., Ltd..

What is the FDA product code for Automatic Micro Needle System (CODE-X)?

The FDA product code for Automatic Micro Needle System (CODE-X) is QAI.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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