Nitinol Thermocouple (TCN) Electrode
FDA 510(k) K183177 · Boston Scientific Corporation
510(k) numberK183177
Submission
- Device name
- Nitinol Thermocouple (TCN) Electrode
- Applicant
- Boston Scientific Corporation
Valencia, CA, US - Received
- November 16, 2018
- Decision date
- March 8, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Nitinol Thermocouple (TCN) Electrode cleared by the FDA?
Nitinol Thermocouple (TCN) Electrode (K183177) received a 510(k) decision of Substantially Equivalent on March 8, 2019, 112 days after the submission was received.
What is the product code of K183177?
The FDA product code is GXI – Probe, Radiofrequency Lesion, a Class II (moderate risk) device regulated under 21 CFR 882.4725.