# K261202: ENTire IRE System

- Pathway: 510(k) (Special)
- Applicant: Entire Medical, Ltd.
- Decided: May 29, 2026 after 46 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K936109 (1994). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251996: ENTire IRE System, Entire Medical, Ltd. (2026) Summary page 5.

## Indications for use
The ENTire IRE System is indicated for the surgical ablation of soft tissue, specifically for otorhinolaryngology (ENT) indications.

Source page: https://510kreport.com/device/K261202
Methodology: https://510kreport.com/methodology