K252282
- 510(k) number
- K252282
- Device name
- SurgiCount+ System
- Applicant
- Stryker Instruments MI · US
- Product code
- PBZ — Image Processing Device For Estimation Of External B
- Decision date
- 2026-03-16
- Date received
- 2025-07-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252282.pdf
Official FDA record: K252282
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.