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FDA 510(k)

Finexel

K-Number: K213557 · 2022-04-12

ApplicantSNJ Co., Ltd.
Decision Date2022-04-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Finexel is the device name listed in this FDA 510(k) record. The listed applicant is SNJ Co., Ltd.. It received FDA 510(k) clearance on 2022-04-12 under 510(k) number K213557. 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 Finexel?

Finexel is a medical device that received FDA 510(k) clearance on 2022-04-12. The listed applicant is SNJ Co., Ltd.. The 510(k) number is K213557.

When did Finexel receive FDA 510(k) clearance?

Finexel received FDA 510(k) clearance on 2022-04-12, under 510(k) number K213557.

Who is the listed applicant for Finexel?

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

What is the FDA product code for Finexel?

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

Other records listing SNJ 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.

K202288Finebeam

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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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