Atlas FDA

Nitinol Thermocouple (TCN) Electrode

FDA 510(k) clearance K183177 · decided 2019-03-08

Clearance details

K-number
K183177
Device name
Nitinol Thermocouple (TCN) Electrode
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2018-11-16
Decision date
2019-03-08
Days to decision
112 days
Clearance type
Special
Product code
GXI
Device class
2
Regulation number
882.4725
Medical specialty
Neurology
Advisory committee
Neurology
Location
Valencia, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 2 recall (Z-2402-2026)Boston Scientific Neuromodulation Corporation2026-06-11
Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.01 recall (Z-2403-2026)Boston Scientific Neuromodulation Corporation2026-06-11
Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for recall (Z-1694-2020)Boston Scientific Neuromodulation Corporation2020-04-10
Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indi recall (Z-1695-2020)Boston Scientific Neuromodulation Corporation2020-04-10
Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for recall (Z-1696-2020)Boston Scientific Neuromodulation Corporation2020-04-10
Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indi recall (Z-1697-2020)Boston Scientific Neuromodulation Corporation2020-04-10
Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for us recall (Z-1698-2020)Boston Scientific Neuromodulation Corporation2020-04-10

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