Sterile Disposables for Mer
FDA 510(k) K120098 · Alpha Omega Engineering , Ltd.
510(k) numberK120098
Submission
- Device name
- Sterile Disposables for Mer
- Applicant
- Alpha Omega Engineering , Ltd.
Zichron Yaacov, IL - Received
- January 12, 2012
- Decision date
- June 12, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code GZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253970 | Wovyn Depth ElectrodeGZL · Traditional | Sensomedical Labs, Ltd. | 04/17/2026SE |
| K250363 | Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth…GZL · Traditional | Beijing Sinovation Medical Technology Co., Ltd. | 11/05/2025SE |
| K250601 | Neuro Omega System; NeuroSmart SystemGZL · Special | Alpha Omega Engineering , Ltd. | 03/30/2025SE |
| K223276 | Anchor Bolts as Accessories to Depth ElectrodesGZL · Traditional | Ad-Tech Medical Instrument Corporation | 05/18/2023SE |
| 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 |
More from Dixi Medical
| 510(k) | Device | Decision |
|---|---|---|
| K250601 | Neuro Omega System; NeuroSmart SystemGZL · Special | 03/30/2025SE |
| K220553 | Neuro Omega System, NeuroSmart SystemGZL · Special | 09/16/2022SE |
| K191739 | Sterile LeadConfirmGZL · Traditional | 01/02/2020SE |
| K172042 | NeuroNav System, NeuroSmart SystemGZL · Traditional | 02/27/2018SE |
| K171581 | Neuro Omega SystemGZL · Traditional | 12/22/2017SE |
| K123796 | Neuro Omega SystemGZL · Traditional | 04/05/2013SE |
| K052527 | NeuroprobesGZL · Traditional | 04/12/2006SE |
| K813333 | Alphatemp Clinical ThermometerFLL · Traditional | 12/31/1981SE |
Questions and answers
When was Sterile Disposables for Mer cleared by the FDA?
Sterile Disposables for Mer (K120098) received a 510(k) decision of Substantially Equivalent on June 12, 2012, 152 days after the submission was received.
What is the product code of K120098?
The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.