# Galvanize Therapeutics, Inc.

- Location (FDA's records): Redwood City, CA
- FDA decisions: 3 (2022–2026): 3 510(k) clearances
- Product codes: OAB (3)
- Predicates its devices cite: 4 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- AngioDynamics, Inc.: 1 (https://510kreport.com/company/angiodynamics)

## Its most-cited devices
- K212871: Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) Electrode (2022), cited by 2
- K233884: INUMI™ Flex Needle (2024), cited by 1

## Recent decisions
- K253826: Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle (May 7, 2026)
- K233884: INUMI™ Flex Needle (May 22, 2024)
- K212871: Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) Electrode (Jun 17, 2022)

Source page: https://510kreport.com/company/galvanize-therapeutics