510(k) K050084 ยท GXI Probe, Radiofrequency Lesion
COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;
| Applicant | Cosman Medical, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Mar 17, 2005 |
| Received | Jan 13, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050084
| 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 |
| Jul 5, 2017 | Cosman Medical, LLC Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12) Terminated |
GXI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.