Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode— 510(k) K212871
Substantially EquivalentGalvanize 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.. Device class: 2.
Clearance details
- Applicant
- Galvanize Therapeutics, Inc.
- Product code
- 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
- San Carlos, CA, US
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More 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.