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510(k) Data Aggregation

    K Number
    K193361
    Device Name
    ProCell Surgical Sponge-Blood Recovery Unit
    Date Cleared
    2020-06-01

    (180 days)

    Product Code
    Regulation Number
    868.5830
    Why did this record match?
    Applicant Name (Manufacturer) :

    ProCell Surgical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ProCell™ facilitates the extraction of blood from surgical sponges as a preliminary step in the process of intraoperative autotransfusion or IAT. ProCell™ functions as a blood collection device only and does not filter or otherwise process the blood recovered. As an accessory to IAT, it is used in conjunction with standard IAT equipment which processes the blood retrieved from ProCellTM prior to reinfusion into the patient (autologous blood transfusion). Designed for ease-of-use directly on the surgical instrument table, the disposable ProCell™ can be used repeatedly during a surgical case and provides an alternative to other sponge-blood recovery methods including hand-wringing.
    Device Description
    The ProCell™ Surgical Sponge - Blood Recovery Unit ("ProCell") automates the manual hand-wringing process to extract blood from surgical sponges. The ProCell unit consists of three components 1) a piston Lid, 2) a perforated Sponge Basket, and 3) a Reservoir. The Sponge Basket is inserted into the Reservoir, and the piston Lid is placed on the top opening of the Reservoir. Through the use of standard Operating Room vacuum suction, blood is extracted from the sponges and is collected in the Reservoir. ProCell is used in conjunction with standard intraoperative autotransfusion devices (IAT) which must process the blood retrieved from ProCell prior to reinfusion into the patient. ProCell functions as a blood collection device only, is not a blood storage container, and does not filter or otherwise process the recovered blood. The recovered blood from ProCell is not intended to be infused directly back into the patient.
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