510(k) K253826— Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle

Substantially Equivalent

Galvanize Therapeutics, Inc.

Clearance details

Applicant: Galvanize Therapeutics, Inc.
Product code: Code OAB
Advisory panel: General, Plastic Surgery
Date received: 2025-12-01
Decision date: 2026-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Adverse events under product code OAB

product code OAB

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.