SurgiCount+ System
FDA 510(k) K232250 · Stryker Instruments
510(k) numberK232250
Submission
- Device name
- SurgiCount+ System
- Applicant
- Stryker Instruments
Portage, MI, US - Received
- July 28, 2023
- Decision date
- January 11, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PBZ – Image Processing Device For Estimation Of External Blood Loss
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2750
- Specialty
- General Hospital
An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images.
Other 510(k)s with product code PBZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252282 | SurgiCount+ SystemPBZ · Traditional | Stryker Instruments | 03/16/2026SE |
| K163507 | Triton Sponge SystemPBZ · Traditional | Gauss Surgical, Inc., | 04/25/2017SE |
| K160338 | Triton SystemPBZ · Traditional | Gauss Surgical, Inc., | 08/05/2016SE |
| K142801 | Triton Canister SystemPBZ · Traditional | Gauss Surgical, Inc., | 03/12/2015SE |
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| K261544 | Hydro Irrigation SystemEOB · Traditional | 06/17/2026SE |
| K253679 | Hydro Irrigation SystemGWG · Traditional | 05/08/2026SE |
| K252282 | SurgiCount+ SystemPBZ · Traditional | 03/16/2026SE |
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Questions and answers
When was SurgiCount+ System cleared by the FDA?
SurgiCount+ System (K232250) received a 510(k) decision of Substantially Equivalent on January 11, 2024, 167 days after the submission was received.
What is the product code of K232250?
The FDA product code is PBZ – Image Processing Device For Estimation Of External Blood Loss, a Class II (moderate risk) device regulated under 21 CFR 880.2750.