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FDA 510(k)

Nitinol Thermocouple (TCN) Electrode

K-Number: K183177 · 2019-03-08

ApplicantBoston Scientific Corporation
Decision Date2019-03-08
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Nitinol Thermocouple (TCN) Electrode is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-03-08 under approval number K183177. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nitinol Thermocouple (TCN) Electrode?

Nitinol Thermocouple (TCN) Electrode is a medical device that received FDA 510(k) clearance on 2019-03-08. It is manufactured by Boston Scientific Corporation. The 510(k) number is K183177.

When was Nitinol Thermocouple (TCN) Electrode approved by the FDA?

Nitinol Thermocouple (TCN) Electrode received FDA 510(k) clearance on 2019-03-08, under approval number K183177.

What company makes Nitinol Thermocouple (TCN) Electrode?

Nitinol Thermocouple (TCN) Electrode is manufactured by Boston Scientific Corporation.

What is the FDA product code for Nitinol Thermocouple (TCN) Electrode?

The FDA product code for Nitinol Thermocouple (TCN) Electrode is GXI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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