510(k) K232250
K232250 is an FDA 510(k) premarket notification submitted by Stryker Instruments for the device "SurgiCount+ System". The FDA issued a decision of Substantially Equivalent on January 11, 2024. The device falls under product code PBZ (Image Processing Device For Estimation Of External Blood Loss), a Class II device regulated under 21 CFR 880.2750. Stryker Instruments has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 2024
- Date Received
- July 28, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Image Processing Device For Estimation Of External Blood Loss
- Device Class
- Class II
- Regulation Number
- 880.2750
- Review Panel
- SU
- Submission Type
An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images.