510(k) K171358
K171358 is an FDA 510(k) premarket notification submitted by Coviden, LLC for the device "Emprint SX Ablation Platform and Accessories". The FDA issued a decision of Substantially Equivalent on Sep 1, 2017. 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
- Sep 1, 2017
- Date Received
- May 9, 2017
- 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)