K233884 is an FDA 510(k) clearance for the INUMI? Flex Needle, a Low Energy Direct Current Thermal Ablation System (Class II — Special Controls, product code OAB), submitted by Galvanize Therapeutics, Inc. (Redwood City, US). The FDA issued a Cleared decision on May 22, 2024, 166 days after receiving the submission on December 8, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K233884 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 08, 2023 |
| Decision Date | May 22, 2024 |
| Days to Decision | 166 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OAB — Low Energy Direct Current Thermal Ablation System |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Ablation Of Soft Tissue |