Bullsai Confirm
FDA 510(k) clearance K243520 · decided 2025-03-28
Clearance details
- K-number
- K243520
- Device name
- Bullsai Confirm
- Applicant
- Turing Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-11-13
- Decision date
- 2025-03-28
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- QQC
- Device class
- 2
- Regulation number
- 882.5855
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Brainlab Elements Guide XT, Guide 3.0 (K213930) | Brainlab AG | 2022-04-19 |
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |
Recalls involving this device
No recalls on record reference this clearance.