K213930 is an FDA 510(k) clearance for the Brainlab Elements Guide XT, Guide 3.0. This device is classified as a Brain Stimulation Programming Planning Software. (Class II - Special Controls, product code QQC).
Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on April 19, 2022, 124 days after receiving the submission on December 16, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5855. The Brain Stimulation Programming Planning Software Is A Prescription Device Intended To Assist In Planning Stimulation Programming For Implanted Brain Stimulators..
| 510(k) Number | K213930 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2021 |
| Decision Date | April 19, 2022 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QQC — Brain Stimulation Programming Planning Software. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5855 |
| Definition | The Brain Stimulation Programming Planning Software Is A Prescription Device Intended To Assist In Planning Stimulation Programming For Implanted Brain Stimulators. |