ENTire IRE System
Device Facts
| Record ID | K261202 |
|---|---|
| Device Name | ENTire IRE System |
| Applicant | Entire Medical , Ltd. |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | May 29, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
