510(k) K233884
K233884 is an FDA 510(k) premarket notification submitted by Galvanize Therapeutics, Inc. for the device "INUMI Flex Needle". The FDA issued a decision of Substantially Equivalent on May 22, 2024. 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
- May 22, 2024
- Date Received
- December 8, 2023
- 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