K261202
- 510(k) number
- K261202
- Device name
- ENTire IRE System
- Applicant
- Entire Medical , Ltd. IL
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2026-05-29
- Date received
- 2026-04-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K261202.pdf
Official FDA record: K261202
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.