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FDA 510(k)

NIRVANA

K-Number: K234057 · 2024-04-10

ApplicantEl.En S.P.A.
Decision Date2024-04-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NIRVANA is the device name listed in this FDA 510(k) record. The listed applicant is El.En S.P.A.. It received FDA 510(k) clearance on 2024-04-10 under 510(k) number K234057. 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 NIRVANA?

NIRVANA is a medical device that received FDA 510(k) clearance on 2024-04-10. The listed applicant is El.En S.P.A.. The 510(k) number is K234057.

When did NIRVANA receive FDA 510(k) clearance?

NIRVANA received FDA 510(k) clearance on 2024-04-10, under 510(k) number K234057.

Who is the listed applicant for NIRVANA?

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

What is the FDA product code for NIRVANA?

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

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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