510(k) K212871
K212871 is an FDA 510(k) premarket notification submitted by Galvanize Therapeutics, Inc. for the device "Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode". The FDA issued a decision of Substantially Equivalent on June 17, 2022. The device falls under product code OAB (Low Energy Direct Current Thermal Ablation System), a Class II device regulated under 21 CFR 878.4400. Galvanize Therapeutics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2022
- Date Received
- September 9, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Low Energy Direct Current Thermal Ablation System
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
Ablation of soft tissue