Microlet Family of Needle/Depth Elect-
FDA 510(k) K802249 · Progress Mankind Technology
510(k) numberK802249
Submission
- Device name
- Microlet Family of Needle/Depth Elect-
- Applicant
- Progress Mankind Technology
Hopkins, MN, US - Received
- September 16, 1980
- Decision date
- November 19, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K253970 | Wovyn Depth ElectrodeGZL · Traditional | Sensomedical Labs, Ltd. | 04/17/2026SE |
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| K250601 | Neuro Omega System; NeuroSmart SystemGZL · Special | Alpha Omega Engineering , Ltd. | 03/30/2025SE |
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| K223269 | Spencer Probe Depth ElectrodesGZL · Traditional | Ad-Tech Medical Instrument Corporation | 05/18/2023SE |
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| 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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| K845035 | Electrode for Neurological Surgery 2111GYC · Traditional | 07/30/1985SN |
| K845036 | Tissue Expanders for Reconstruc-Surgery 3600LCJ · Traditional | 06/26/1985SE |
| K834047 | Pmt-Halo/Orthopedic Jacket SystemHAX · Traditional | 02/17/1984SE |
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Questions and answers
When was Microlet Family of Needle/Depth Elect- cleared by the FDA?
Microlet Family of Needle/Depth Elect- (K802249) received a 510(k) decision of Substantially Equivalent on November 19, 1980, 64 days after the submission was received.
What is the product code of K802249?
The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.