Class Class II

ENTire IRE System (K251996)

K251996 2026-01-14 Traditional
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Description

ENTire IRE System by Entire Medical , Ltd., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251996
Clearance Date2026-01-14
Clearance TypeTraditional
Product CodeGEI
Regulation Number878.4400

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