510(k) K223272
K223272 is an FDA 510(k) premarket notification submitted by Mima-Pro Scientific, Inc. for the device "SurBlate Ablation System". The FDA issued a decision of Substantially Equivalent on February 28, 2023. 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
- February 28, 2023
- Date Received
- October 24, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Ablation, Microwave And Accessories
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type