FDA 510(k)

Automatic Micro Needle System (CODE-X)

K-Nummer: K252591 · 2026-05-13

AntragstellerWoorhi Mechatronics Co., Ltd.

Entscheidungsdatum2026-05-13

ProduktcodeQAI

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

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

Häufig gestellte Fragen

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. The listed applicant is Woorhi Mechatronics Co., Ltd.. The 510(k) number is K252591.

When did Automatic Micro Needle System (CODE-X) receive FDA 510(k) clearance?

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

Who is the listed applicant for Automatic Micro Needle System (CODE-X)?

The FDA 510(k) record lists Woorhi Mechatronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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