Emprint Ablation System with Thermosphere Technology
FDA 510(k) K200796 · Covidien, LLC
510(k) numberK200796
Submission
- Device name
- Emprint Ablation System with Thermosphere Technology
- Applicant
- Covidien, LLC
Boulder, CO, US - Received
- March 26, 2020
- Decision date
- August 26, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEY – System, Ablation, Microwave And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Emprint Ablation System with Thermosphere Technology cleared by the FDA?
Emprint Ablation System with Thermosphere Technology (K200796) received a 510(k) decision of Substantially Equivalent on August 26, 2020, 153 days after the submission was received.
What is the product code of K200796?
The FDA product code is NEY – System, Ablation, Microwave And Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.