Manufacturer
Entire Medical , Ltd.ENTire IRE System
Country / Region:Israel (IL)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Device details
FDA 510(k) registration fields
- K number
- K251996
- Device name
- ENTire IRE System
- Company
- Entire Medical , Ltd.
- Country / Region
- Israel(IL)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-06-27
- Decision date
- 2026-01-14
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- Surgery
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The ENTire IRE System is indicated for the surgical ablation of soft tissue, specifically for otorhinolaryngology (ENT) indications.
Intended Use
The ENTire IRE System is indicated for the surgical ablation of soft tissue, specifically for otorhinolaryngology (ENT) indications.
Device Description
The ENTire IRE System includes a reusable electrosurgical generator activated by a foot pedal and single-use handpieces which are provided sterile. The ENTire IRE System utilizes irreversible electroporation ('IRE'), a nonthermal ablation technology that delivers high-voltage, low-energy electrical pulses to tissue via bipolar electrodes. The system generates irreversible nanopores in the cell membranes, altering the cell membrane characteristics, and inducing apoptosis. The dead cells are then resorbed leading to tissue reduction.Summary parsed at:2026-06-19 23:51:35 UTC
Predicate devices
2Cited as predicate
1ENTire IRE System
1 submission cite K251996 as a predicate