Other
SurgiCount+ System
Stryker Instruments
FDA
FDA-cleared AI medical device
Multifunctional surgical-safety software that counts and locates RFID-tagged surgical sponges and analyzes images of used sponges to estimate hemoglobin mass and blood loss during surgery, supporting clinicians in sponge management and blood-loss assessment.
FDA Submission Metadata
- Submission number
- K252282
- Decision date
- March 2026
- FDA panel
- General Hospital
- Product code
- PBZ
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA