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FDA 510(k)

EASYMADE-TI

K-Number: K252251 · 2026-04-09

ApplicantCG Bio Co., Ltd.
Decision Date2026-04-09
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EASYMADE-TI is the device name listed in this FDA 510(k) record. The listed applicant is CG Bio Co., Ltd.. It received FDA 510(k) clearance on 2026-04-09 under 510(k) number K252251. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASYMADE-TI?

EASYMADE-TI is a medical device that received FDA 510(k) clearance on 2026-04-09. The listed applicant is CG Bio Co., Ltd.. The 510(k) number is K252251.

When did EASYMADE-TI receive FDA 510(k) clearance?

EASYMADE-TI received FDA 510(k) clearance on 2026-04-09, under 510(k) number K252251.

Who is the listed applicant for EASYMADE-TI?

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

What is the FDA product code for EASYMADE-TI?

The FDA product code for EASYMADE-TI is GXN.

Other records listing CG Bio Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GXN)

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Official Source

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

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