510(k) K192406
K192406 is an FDA 510(k) premarket notification submitted by Medwaves, Inc. for the device "AveCure BT Microwave Ablation System". The FDA issued a decision of Substantially Equivalent on Nov 25, 2020. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 25, 2020
- Date Received
- Sep 4, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Ablation, Microwave And Accessories
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
- 510(k)