510(k) K970943
- Device
- GUIDELINE SYSTEM
- Applicant
- AXON INSTRUMENTS, INC.
- 510(k) number
- K970943
- Product code
- GZL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-08-18
- Date received
- 1997-03-14
- Regulation
- 882.1330
- Classification name
- Electrode, Depth
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANDREW L BLATZ
- Address
- 1101 Chess Dr. Foster City CA US 94404 94404
FDA Registration Numbers#
- 1064858
- 2183744
- 2528981
- 3024996452
- 8043398
- 3016438686
- 3002250546
- 3000203391
- 3008534770
- 2183456
- 3002808227
- 3008102042
- 3007323246
- 1721676
- 3005581270
- 3009766315
- 3007636029
- 9615126
- 2182979
- 3008773490
- 3006258094
- 3010383847
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GZL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253970 | Wovyn Depth Electrode | Sensomedical Labs, Ltd. | 2026-04-17 |
| K250363 | Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept | Beijing Sinovation Medical Technology Co., Ltd. | 2025-11-05 |
| K250601 | Neuro Omega System; NeuroSmart System | Alpha Omega Engineering , Ltd. | 2025-03-30 |
| K223276 | Anchor Bolts as Accessories to Depth Electrodes | Ad-Tech Medical Instrument Corporation | 2023-05-18 |
| K223269 | Spencer Probe Depth Electrodes | Ad-Tech Medical Instrument Corporation | 2023-05-18 |
| K213170 | SENSOSEEG Depth Electrodes | Sensomedical Labs, Ltd. | 2023-04-18 |
| K222706 | iCE-SG2 Subcutaneous Electrode Kit | Ice Neurosystems, Inc. | 2022-12-06 |
| K222404 | Evo® sEEG System | Neuroone Medical Technologies Corp. | 2022-10-20 |
| K220553 | Neuro Omega System, NeuroSmart System | Alpha Omega Engineering , Ltd. | 2022-09-16 |
| K202087 | DIXI Medical Microdeep Micro-Macro Depth Electrodes | Dixi Medical | 2021-11-18 |
| K211367 | Evo sEEG System | Neuroone Medical Technologies Corp. | 2021-09-01 |
| K201678 | iCE-SG Subcutaneous Electrode Arrays | Ice Neurosystems, Inc. | 2021-03-08 |
| K191739 | Sterile LeadConfirm | Alpha Omega Engineering , Ltd. | 2020-01-02 |
| K183123 | microTargeting Guideline 4000 5.0 System | FHC, Inc. | 2018-12-20 |
| K181544 | Anchor Bolt (as an accessory to Depth Electrodes) | Ad-Tech Medical Instrument Corporation | 2018-08-09 |
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