SurgiCount+ System is an AI-enabled medical device from Stryker Instruments that the U.S. FDA cleared through 510(k) K232250 on January 11, 2024. Its lead review panel is General Hospital and its primary product code is PBZ (Image Processing Device For Estimation Of External Blood Loss).
See also all FDA AI clearances in 2024.
Key facts
| Submission number | K232250 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Stryker Instruments |
| Lead review panel | General Hospital |
| Primary product code | PBZ — Image Processing Device For Estimation Of External Blood Loss |
| Applicant (openFDA) | Stryker Instruments |
| Applicant location | Portage, MI, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 880.2750 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. SurgiCount+ System went through this pathway (K232250).
openFDA lists it as a Class 2 device under 21 CFR 880.2750. Class II devices are moderate risk and are subject to general and special controls.
Product code PBZ covers 3 devices on the FDA AI list. By decision date, this device is #2 of 3 under that code. Stryker Instruments has 2 AI-enabled devices on the list, and the General Hospital panel accounts for 6 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.
Similar devices (product code PBZ)
- SurgiCount+ SystemStryker Instruments · General Hospital
- Triton SystemGAUSS SURGICAL INC. · General Hospital