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FDA 510(k)

ENTire IRE System

K-Number: K251996 · 2026-01-14

ApplicantEntire Medical , Ltd.
Decision Date2026-01-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENTire IRE System is a medical device manufactured by Entire Medical , Ltd.. It received FDA 510(k) clearance on 2026-01-14 under approval number K251996. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTire IRE System?

ENTire IRE System is a medical device that received FDA 510(k) clearance on 2026-01-14. It is manufactured by Entire Medical , Ltd.. The 510(k) number is K251996.

When was ENTire IRE System approved by the FDA?

ENTire IRE System received FDA 510(k) clearance on 2026-01-14, under approval number K251996.

What company makes ENTire IRE System?

ENTire IRE System is manufactured by Entire Medical , Ltd..

What is the FDA product code for ENTire IRE System?

The FDA product code for ENTire IRE System is GEI.

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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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