K193232 is an FDA 510(k) clearance for the Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology. This device is classified as a System, Ablation, Microwave And Accessories (Class II - Special Controls, product code NEY).
Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on February 13, 2020, 80 days after receiving the submission on November 25, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K193232 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2019 |
| Decision Date | February 13, 2020 |
| Days to Decision | 80 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEY — System, Ablation, Microwave And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |