Cosman Rf Lesion Generator, Model Rfg-1A; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal Electrode Kit;

510(k) K050084

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK050084	Date17 Mar 2005Cleared	StatusActive

3 recalls · 2 ongoing · FDA

2 recalls, same reason
- Ongoing Z-2402-2026 FDA Class II initiated 29 Apr 2026
- Ongoing Z-2403-2026 FDA Class II initiated 29 Apr 2026
Reusable electrodes may not meet expected performance levels.
- Terminated Z-0687-2018 FDA Class II initiated 5 Jul 2017
After multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can exhibit signs of damage. In some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilizing the device.

1 jurisdiction

United States — FDA 510(k) Active

510(k)

510(k) Number: K050084
FDA Product Code: GXI
Models / Variants: Cosman Rf Lesion Generator, Model Rfg-1A
Cosman Tew Trigeminal Electrode Kit
Cosman Tic Trigeminal Electrode Kit