510(k) K200796
K200796 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Emprint Ablation System with Thermosphere Technology". The FDA issued a decision of Substantially Equivalent on Aug 26, 2020. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Covidien, LLC has 224 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 26, 2020
- Date Received
- Mar 26, 2020
- 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)