510(k) Report

Devices descending from K050084

20 later devices reach Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.20250—
+1K183177Nitinol Thermocouple (TCN) ElectrodeBoston Scientific Corporation201907
+1K082051Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc.20087—
+1K082012Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc.20083—
+1K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc.20069—
+1K053415Lesionpoint RF CannulaCosman Medical, Inc.200610—
+2K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit…Boston Scientific Neuromodulation Corporation20250—
+2K231675OneRF Ablation SystemNeuroone Medical Technologies Corp.20231—
+2K141586Owl CannulaeDiros Technology, Inc.20142—
+2K123178Stryker Venom Electrodes and CannulaeStryker Instruments, Instruments Div.20132—
+2K111576NT 2000 Lesioning GeneratorNeuro Therm, Inc.201134
+2K102566Owl CannulaeDiros Technology, Inc.20113—
+2K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp.20084—
+3K232632Racz Neurostat RF GeneratorEpimed International20240—
+3K220122APEX 6Rf Innovations, Inc.20230—
+3K201610IonicRF GeneratorAbbott Medical20200—
+3K191293LCCS VC-S RF CannulaLccs Products Limited20200—
+3K190256Rulo Radiofrequency Lesion ProbeEpimed International, Inc.20190—
+3K170242MultiGen™ 2 RF Generator SystemStryker Corporation20170—
+3K150371Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRHDiros Technology, Inc.20150—