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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 the device name listed in this FDA 510(k) record. The listed applicant is Entire Medical , Ltd.. It received FDA 510(k) clearance on 2026-01-14 under 510(k) 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. The listed applicant is Entire Medical , Ltd.. The 510(k) number is K251996.

When did ENTire IRE System receive FDA 510(k) clearance?

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

Who is the listed applicant for ENTire IRE System?

The FDA 510(k) record lists Entire Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENTire IRE System?

The FDA product code for ENTire IRE System is GEI.

Related Clinical Trials

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.

NCT06960239Safety and Efficacy of the Irreversible Electroporation (IRE) System for Adenotonsillar Hypertrophy in ChildrenCOMPLETED

Other records listing Entire Medical , Ltd. 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.

K261202ENTire IRE System

Related Devices (Code: GEI)

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.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

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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