ENTire IRE System— 510(k) K261202
Substantially EquivalentEntire Medical , Ltd.
FDA 510(k) clearance K261202 for ENTire IRE System, Substantially Equivalent on 2026-05-29. Applicant: Entire Medical , Ltd.. Device class: 2.
Summary
The ENTire IRE System comes from Entire Medical and is filed under GEI, electrosurgical cutting and coagulation devices and accessories. The record doesn't expand "IRE".
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Special 510(k).
Entire Medical filed from Herzeliya, Israel. Review took 46 calendar days (April 13 to May 29, 2026).
Clearance details
- Applicant
- Entire Medical , Ltd.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Herzeliya, IL
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More clearances from Entire Medical , Ltd.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.