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FDA 510(k)

ECHOLASER X4

K-Number: K213594 · 2022-05-03

ApplicantElesta S.P.A
Decision Date2022-05-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ECHOLASER X4 is the device name listed in this FDA 510(k) record. The listed applicant is Elesta S.P.A. It received FDA 510(k) clearance on 2022-05-03 under 510(k) number K213594. 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 ECHOLASER X4?

ECHOLASER X4 is a medical device that received FDA 510(k) clearance on 2022-05-03. The listed applicant is Elesta S.P.A. The 510(k) number is K213594.

When did ECHOLASER X4 receive FDA 510(k) clearance?

ECHOLASER X4 received FDA 510(k) clearance on 2022-05-03, under 510(k) number K213594.

Who is the listed applicant for ECHOLASER X4?

The FDA 510(k) record lists Elesta S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHOLASER X4?

The FDA product code for ECHOLASER X4 is GEX. This falls under the Gastroenterology category.

Other records listing Elesta S.P.A 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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