FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SurgiCount+ System
K Number: K252282
·
Decision Mar 16, 2026
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
5
Applicant Total
74
Review Days
237
Basic Information
- Device Name
- SurgiCount+ System
- K Number
- K252282
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2750
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Instruments
- Date Received
- July 22, 2025
- Decision Date
- March 16, 2026
- Product Code
- PBZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PBZ | Image Processing Device For Estimation Of External Blood Loss | FDA class 2 | General Hospital |
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