K233884
- 510(k) number
- K233884
- Device name
- INUMI Flex Needle
- Applicant
- Galvanize Therapeutics, Inc. CA · US
- Product code
- OAB — Low Energy Direct Current Thermal Ablation System
- Decision date
- 2024-05-22
- Date received
- 2023-12-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233884.pdf
Official FDA record: K233884
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.