K243520 is an FDA 510(k) clearance for the Bullsai Confirm. This device is classified as a Brain Stimulation Programming Planning Software. (Class II - Special Controls, product code QQC).
Submitted by Turing Medical Technologies, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 28, 2025, 135 days after receiving the submission on November 13, 2024.
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 | K243520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2024 |
| Decision Date | March 28, 2025 |
| Days to Decision | 135 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. |