510(k) Report

Devices descending from K991399

28 later devices reach Radionics Microelectrode Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050084Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman…Cosman Medical, Inc.2005203
+1K012850Recording and Stimulating ElectrodeRadionics, A Division of Tyco Healthcare Group LP20016—
+2K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.20250—
+2K183177Nitinol Thermocouple (TCN) ElectrodeBoston Scientific Corporation201907
+2K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical201759
+2K082051Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc.20087—
+2K082012Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc.20083—
+2K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc.20069—
+2K053415Lesionpoint RF CannulaCosman Medical, Inc.200610—
+3K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth…Beijing Sinovation Medical Technology Co., Ltd.20250—
+3K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit…Boston Scientific Neuromodulation Corporation20250—
+3K231675OneRF Ablation SystemNeuroone Medical Technologies Corp.20231—
+3K213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd.20231—
+3K211367Evo sEEG SystemNeuroone Medical Technologies Corp.20212—
+3K141586Owl CannulaeDiros Technology, Inc.20142—
+3K123178Stryker Venom Electrodes and CannulaeStryker Instruments, Instruments Div.20132—
+3K111576NT 2000 Lesioning GeneratorNeuro Therm, Inc.201134
+3K102566Owl CannulaeDiros Technology, Inc.20113—
+3K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp.20084—
+4K253970Wovyn Depth ElectrodeSensomedical Labs, Ltd.20260—
+4K232632Racz Neurostat RF GeneratorEpimed International20240—
+4K220122APEX 6Rf Innovations, Inc.20230—
+4K222404Evo® sEEG SystemNeuroone Medical Technologies Corp.20221—
+4K201610IonicRF GeneratorAbbott Medical20200—
+4K191293LCCS VC-S RF CannulaLccs Products Limited20200—
+4K190256Rulo Radiofrequency Lesion ProbeEpimed International, Inc.20190—
+4K170242MultiGen™ 2 RF Generator SystemStryker Corporation20170—
+4K150371Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRHDiros Technology, Inc.20150—