# K253826: Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle

- Pathway: 510(k) (Traditional)
- Applicant: Galvanize Therapeutics, Inc.
- Decided: May 7, 2026 after 157 days
- Product code: OAB (Low Energy Direct Current Thermal Ablation System)
- 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 K942299 (1995). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212871: Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) Electrode, Galvanize Therapeutics, Inc. (2022) Summary page 5.
- K233884: INUMI™ Flex Needle, Galvanize Therapeutics, Inc. (2024) Summary page 5.

## Indications for use
The Aliya@ EX System is indicated for surgical ablation of soft tissue. The Aliya@ Needle is intended for use as part of the Aliya@ System and Aliya EX@ System for surgical ablation of soft tissue. The Aliya@ Electrode is intended for use as part of the Aliya® System and Aliya EX@ System for surgical ablation of soft tissue. The INUMI TM Flex Needle is intended for use as part of the Aliya® System and Aliya EX@ System for surgical ablation of soft tissue.

Source page: https://510kreport.com/device/K253826
Methodology: https://510kreport.com/methodology