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FDA 510(k)

Leaseir MHR Xcell

K-Number: K214049 · 2022-06-02

ApplicantLeaseir Technologies, Slu
Decision Date2022-06-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Leaseir MHR Xcell is the device name listed in this FDA 510(k) record. The listed applicant is Leaseir Technologies, Slu. It received FDA 510(k) clearance on 2022-06-02 under 510(k) number K214049. 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 Leaseir MHR Xcell?

Leaseir MHR Xcell is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is Leaseir Technologies, Slu. The 510(k) number is K214049.

When did Leaseir MHR Xcell receive FDA 510(k) clearance?

Leaseir MHR Xcell received FDA 510(k) clearance on 2022-06-02, under 510(k) number K214049.

Who is the listed applicant for Leaseir MHR Xcell?

The FDA 510(k) record lists Leaseir Technologies, Slu as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Leaseir MHR Xcell?

The FDA product code for Leaseir MHR Xcell is GEX. This falls under the Gastroenterology category.

Other records listing Leaseir Technologies, Slu 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.

K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)

Related Devices (Code: GEX)

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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