Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
FDA 510(k) K193232 · Covidien, LLC
510(k) numberK193232
Submission
- Device name
- Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
- Applicant
- Covidien, LLC
Boulder, CO, US - Received
- November 25, 2019
- Decision date
- February 13, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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, Emprint SX Ablation Platform with Thermosphere Technology cleared by the FDA?
Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology (K193232) received a 510(k) decision of Substantially Equivalent on February 13, 2020, 80 days after the submission was received.
What is the product code of K193232?
The FDA product code is NEY – System, Ablation, Microwave And Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.