510(k) K183177 ยท GXI Probe, Radiofrequency Lesion
Nitinol Thermocouple (TCN) Electrode
| Applicant | Boston Scientific Corporation, Valencia CA, US |
| Decision | Substantially Equivalent, Mar 8, 2019 |
| Received | Nov 16, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183177
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2026 | Boston Scientific Neuromodulation Corporation Boston Scientific CSK Electrodes:
REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm)
REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm);
REF: CSK-TC Open, Classified |
GXI | None listed |
| Jun 11, 2026 | Boston Scientific Neuromodulation Corporation Boston Scientific TCN Electrodes:
REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in);
REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in)
REF:TCN-15, TCN Electrode, NITINOL, 15 Open, Classified |
GXI | None listed |
| Apr 10, 2020 | Boston Scientific Neuromodulation Corporation Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sen Terminated |
GXI | None listed |
| Apr 10, 2020 | Boston Scientific Neuromodulation Corporation Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are tempe Terminated |
GXI | None listed |
| Apr 10, 2020 | Boston Scientific Neuromodulation Corporation Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sen Terminated |
GXI | None listed |
| Apr 10, 2020 | Boston Scientific Neuromodulation Corporation Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are tempe Terminated |
GXI | None listed |
| Apr 10, 2020 | Boston Scientific Neuromodulation Corporation Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensi Terminated |
GXI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.