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FDA 510(k)

Lucas Plus

K-Number: K230340 · 2023-05-04

ApplicantAmt Engineering Co., Ltd.
Decision Date2023-05-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Lucas Plus is the device name listed in this FDA 510(k) record. The listed applicant is Amt Engineering Co., Ltd.. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K230340. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lucas Plus?

Lucas Plus is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Amt Engineering Co., Ltd.. The 510(k) number is K230340.

When did Lucas Plus receive FDA 510(k) clearance?

Lucas Plus received FDA 510(k) clearance on 2023-05-04, under 510(k) number K230340.

Who is the listed applicant for Lucas Plus?

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

What is the FDA product code for Lucas Plus?

The FDA product code for Lucas Plus is GEX. This falls under the Gastroenterology category.

Other records listing Amt Engineering 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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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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