Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode— 510(k) K212871

Substantially Equivalent

Galvanize Therapeutics, Inc.

FDA 510(k) clearance K212871 for Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode, Substantially Equivalent on 2022-06-17. Applicant: Galvanize Therapeutics, Inc..

Clearance details

Applicant: Galvanize Therapeutics, Inc.
Product code: Code OAB
Advisory panel: General, Plastic Surgery
Date received: 2021-09-09
Decision date: 2022-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Carlos, CA, US

Download summary PDF View on FDA.gov ↗

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.