SurgiCount+ System— 510(k) K252282
Substantially EquivalentStryker Instruments
FDA 510(k) clearance K252282 for SurgiCount+ System, Substantially Equivalent on 2026-03-16. Applicant: Stryker Instruments. Device class: 2.
Summary
Stryker Instruments' SurgiCount+ System is filed under PBZ, image processing devices for estimation of external blood loss. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 880.2750. The Obstetrics/Gynecology review panel handled it as a Traditional 510(k), though the record lists General Hospital as the classification panel.
Stryker Instruments filed from Portage, Michigan. The decision came 237 calendar days after receipt (July 22, 2025 to March 16, 2026).
Clearance details
- Applicant
- Stryker Instruments
- Product code
- Product code PBZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.2750
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portage, MI, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.