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FDA 510(k)

XLase Plus

K-Number: K212790 · 2022-08-15

ApplicantBiotec Italia, Srl
Decision Date2022-08-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XLase Plus is the device name listed in this FDA 510(k) record. The listed applicant is Biotec Italia, Srl. It received FDA 510(k) clearance on 2022-08-15 under 510(k) number K212790. 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 XLase Plus?

XLase Plus is a medical device that received FDA 510(k) clearance on 2022-08-15. The listed applicant is Biotec Italia, Srl. The 510(k) number is K212790.

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

XLase Plus received FDA 510(k) clearance on 2022-08-15, under 510(k) number K212790.

Who is the listed applicant for XLase Plus?

The FDA 510(k) record lists Biotec Italia, Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XLase Plus?

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

Related Devices (Code: GEX)

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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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