# K183177: Nitinol Thermocouple (TCN) Electrode

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Mar 8, 2019 after 112 days
- Product code: GXI (Probe, Radiofrequency Lesion)
- Device class: 2
- Regulation: 21 CFR 882.4725
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K870028 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050084: Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal Electrode Kit;, Cosman Medical, Inc. (2005) Summary page 4.

## Recalls of this device
- Apr 29, 2026 · Class II · Z-2403-2026: Reusable electrodes may not meet expected performance levels.
- Apr 29, 2026 · Class II · Z-2402-2026: Reusable electrodes may not meet expected performance levels.
- May 30, 2019 · Class II · Z-1694-2020: The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
- May 30, 2019 · Class II · Z-1697-2020: The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
- May 30, 2019 · Class II · Z-1695-2020: The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
- May 30, 2019 · Class II · Z-1696-2020: The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
- May 30, 2019 · Class II · Z-1698-2020: The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.

## Indications for use
The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.

Source page: https://510kreport.com/device/K183177
Methodology: https://510kreport.com/methodology