Data / Medical devices / United States / Galvanize Therapeutics
Galvanize Therapeutics: FDA-registered device maker in Redwood City, CA, United States, 3 510(k) clearances
Galvanize Therapeutics is registered with the FDA (registration 3017185164) in Redwood City, CA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 7, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017185164
- Address
- 3200 Bridge Parkway, Redwood City, CA, United States, 94065
- Owner or operator
- Galvanize Therapeutics (10083741)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- June 27, 2023
- Registered through
- 2026
- Brand names listed
- Aliya EX System, Aliya System, Galvanize Cart, INUMI Flex Needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Low Energy Direct Current Thermal Ablation System | OAB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 7, 2026 | K253826 | Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle | OAB | Substantially Equivalent | Galvanize Therapeutics, Inc. | accessdata.fda.gov |
| May 22, 2024 | K233884 | INUMI Flex Needle | OAB | Substantially Equivalent | Galvanize Therapeutics, Inc. | accessdata.fda.gov |
| June 17, 2022 | K212871 | Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode | OAB | Substantially Equivalent | Galvanize Therapeutics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Low Energy Direct Current Thermal Ablation System
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Updated May 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.