Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle— 510(k) K253826
Substantially EquivalentGalvanize Therapeutics, Inc.
FDA 510(k) clearance K253826 for Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle, Substantially Equivalent on 2026-05-07. Applicant: Galvanize Therapeutics, Inc.. Device class: 2.
Summary
Galvanize Therapeutics' record lists five items: the Aliya EX System, Aliya EX Generator, Aliya Needle, Aliya Electrode, and INUMI Flex Needle. The product code is OAB, low energy direct current thermal ablation systems.
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Galvanize filed from Redwood City, California. Review took 157 calendar days (December 1, 2025 to May 7, 2026).
Clearance details
- Applicant
- Galvanize Therapeutics, Inc.
- Product code
- Product code OAB
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood City, CA, US
Recent devices under product code OAB
view allMore clearances from Galvanize Therapeutics, Inc.
view allAdverse events under product code OAB
product code OAB- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.