510(k) K252282
- Device
- SurgiCount+ System
- Applicant
- Stryker Instruments
- 510(k) number
- K252282
- Product code
- PBZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-16
- Date received
- 2025-07-22
- Regulation
- 880.2750
- Classification name
- Image Processing Device For Estimation Of External Blood Loss
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Michael Mazelin
- Address
- 1941 Stryker Way Portage MI US 49002 49002
FDA Registration Numbers#
- 3015967359
- 3010141593
Source Documents#
Other 510(k) Records For Product Code PBZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232250 | SurgiCount+ System | Stryker Instruments | 2024-01-11 |
| K163507 | Triton Sponge System | Gauss Surgical, Inc., | 2017-04-25 |
| K160338 | Triton System | Gauss Surgical, Inc., | 2016-08-05 |
| K142801 | Triton Canister System | Gauss Surgical, Inc., | 2015-03-12 |
| DEN130015 | PIXEL 3 SYSTEM | Gauss Surgical, Inc., | 2014-05-09 |