Guideline System
FDA 510(k) K970943 · Axon Instruments, Inc.
510(k) numberK970943
Submission
- Device name
- Guideline System
- Applicant
- Axon Instruments, Inc.
Foster City, CA, US - Received
- March 14, 1997
- Decision date
- August 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code GZL
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|---|---|---|---|
| K253970 | Wovyn Depth ElectrodeGZL · Traditional | Sensomedical Labs, Ltd. | 04/17/2026SE |
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| K223269 | Spencer Probe Depth ElectrodesGZL · Traditional | Ad-Tech Medical Instrument Corporation | 05/18/2023SE |
| K213170 | SENSOSEEG Depth ElectrodesGZL · Traditional | Sensomedical Labs, Ltd. | 04/18/2023SE |
| K222706 | iCE-SG2 Subcutaneous Electrode KitGZL · Traditional | Ice Neurosystems, Inc. | 12/06/2022SE |
| K222404 | Evo® sEEG SystemGZL · Traditional | Neuroone Medical Technologies Corp. | 10/20/2022SE |
| K220553 | Neuro Omega System, NeuroSmart SystemGZL · Special | Alpha Omega Engineering , Ltd. | 09/16/2022SE |
| K202087 | DIXI Medical Microdeep Micro-Macro Depth ElectrodesGZL · Traditional | Dixi Medical | 11/18/2021SE |
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Questions and answers
When was Guideline System cleared by the FDA?
Guideline System (K970943) received a 510(k) decision of Substantially Equivalent on August 18, 1997, 157 days after the submission was received.
What is the product code of K970943?
The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.