K233884 is an FDA 510(k) clearance for the INUMI™ Flex Needle. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.4400. Ablation Of Soft Tissue.
| 510(k) Number | K233884 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |