510(k) K926424
- Device
- CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON
- Applicant
- RADIONICS, INC.
- 510(k) number
- K926424
- Product code
- GYC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-11-19
- Date received
- 1992-12-23
- Regulation
- 882.1310
- Classification name
- Electrode, Cortical
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LINDA JALBERT
- Address
- P.O. Box 438 76 Cambridge St. Burlington MA US 01803 01803
FDA Registration Numbers#
- 9612330
- 2080783
- 2183744
- 3009391672
- 3003418325
- 3024996452
- 3013501110
- 3011534533
- 3016438686
- 3010611950
- 3005713796
- 2183456
- 3002806603
- 3007611554
- 3007323246
- 3007962724
- 8030229
- 3009766315
- 3006849754
- 9611252
- 3016852448
- 3030387292
- 3007636029
- 2184161
- 3007156625
- 9615126
- 3008008477
- 2182979
- 3020018
Source Documents#
Other 510(k) Records For Product Code GYC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250094 | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) | Neuralynx, Inc. | 2025-04-14 |
| K242618 | Layer 7-T | Precision Neuroscience, Corp. | 2025-03-30 |
| K221123 | WISE Cortical Strip (WCS) | Wise S.R.L. | 2022-11-22 |
| K211954 | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid | Spes Medica Srl | 2022-11-10 |
| K201931 | Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) | Dixi Medical | 2021-10-02 |
| K191346 | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) | Blackrock Microsystems | 2020-02-14 |
| K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode | Ad-Tech Medical Instrument Corporation | 2020-01-25 |
| K192764 | NeuroOne Cortical Electrode | Neuroone, Inc. | 2019-11-26 |
| K183437 | AirRay Subdural Cortical Electrodes | Cortec GmbH | 2019-03-12 |
| K180761 | SD LTM STIM Cortical Stimulator | Micromed S.P.A. | 2018-06-18 |
| K173684 | g.Estim PRO | G.Tec Medical Engineering GmbH | 2018-05-04 |
| K151354 | Cervello STIM | Blackrock Neuromed | 2016-01-27 |
| K110410 | MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) | Nihon Kohden Corp. | 2011-08-04 |
| K102802 | INTEGRA ELECTRODE TUNNELING NEEDLE | Integra LifeSciences Corporation | 2010-11-23 |
| K082629 | S12X WITH ESAX OPTION | Chatten Associates, Inc. | 2009-07-01 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases