K251996 is an FDA 510(k) clearance for the ENTire IRE System. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.
Submitted by Entire Medical , Ltd. (Herzeliya, IL). The FDA issued a Cleared decision on January 14, 2026 after a review of 201 days - an extended review cycle.
This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.
View all Entire Medical , Ltd. devices
NCT06187194
Completed
Interventional
Industry-sponsored
Efficacy and Safety of Irreversible Electroporation for Chronic Symptomatic Tonsillar Hypertrophy Treatment
Evaluation of the Efficacy and Safety of an Irreversible Electroporation (IRE) System for Tonsil Reduction for The Treatment of Chronic Symptomatic Tonsillar Hypertrophy
| Condition studied |
Tonsillar Hypertrophy |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Sponsor |
ENTire Medical Ltd.
(industry)
|
Started 2024-01-17
→
Primary completion 2024-11-15
→
Completed 2025-02-02
Primary outcome
Change of Tonsil(s) Size at 3 Months Compared to the Baseline.
Secondary outcome
Change in Snore VAS at 3-months Post-treatment Compared to Baseline
View full study on ClinicalTrials.gov