Devices · Stryker Instruments

SurgiCount+ System

Stryker Instruments is listed for SurgiCount+ System (K232250). The FDA list gives January 11, 2024 as the date of the final decision. The lead panel is General Hospital, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PBZ as “Image Processing Device For Estimation Of External Blood Loss”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232250

Official FDA database record

Date of final decision

January 11, 2024

Company on the FDA list

Stryker Instruments

Lead panel

General Hospital

Primary product code

PBZ

openFDA device name for the code

Image Processing Device For Estimation Of External Blood Loss

Device class

2

Regulation number

880.2750

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary