The following data is part of a premarket notification filed by Galvanize Therapeutics, Inc. with the FDA for Aliya(tm) System, Aliya(tm) Generator, Aliya(tm) Needle, Aliya(tm) Electrode.
| Device ID | K212871 |
| 510k Number | K212871 |
| Device Name: | Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode |
| Classification | Low Energy Direct Current Thermal Ablation System |
| Applicant | Galvanize Therapeutics, Inc. 1531 Industrial Road San Carlos, CA 94070 |
| Contact | Deborah Sheffield |
| Correspondent | Lisa L. Pritchard DuVal & Assoicates, P.A. 1820 Medical Arts Building 825 Nicollet Mall Minneapolis, MN 55402 |
| Product Code | OAB |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-09 |
| Decision Date | 2022-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850031859050 | K212871 | 000 |
| 10850031859026 | K212871 | 000 |
| 10850031859002 | K212871 | 000 |