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510(k) Data Aggregation

    K Number
    K250388
    Device Name
    ENDOFLATOR +
    Manufacturer
    Karl Storz SE & Co. KG
    Date Cleared
    2025-09-22

    (223 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K201361
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ENDOFLATOR + is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with CO2 gas with the following operating modes:

    • High Flow and Pediatric modes are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure.
    • Pediatric mode is indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure in pediatrics aged 2 and up.
    • EVH mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.
    • taTME mode is indicated to fill and distend the rectum and colon using CO2 gas during transanal minimally invasive surgery.
    Device Description

    The ENDOFLATOR + is an insufflation device with integrated smoke evacuation for laparoscopic examinations and surgery as well as transanal endoscopy and endoscopic vessel harvesting. Insufflation creates and maintains a cavity in the patient's body. The subject device offers four operating modes: High Flow, Pediatric, EVH, and taTME.

    Smoke evacuation can be used with different flow rates for removal and filtration of CO2 and surgical smoke during operation.

    The ENDOFLATOR + is operated directly on the touchscreen. All data required during the surgery is displayed simultaneously on the touchscreen.

    The subject device is to be used with one of the following tube sets depending on the selected mode and desired features (smoke evacuation, heating, and humidification) needed: UI610 (standard), UI611 (heating), UI612 (smoke evacuation), UI613 (heating + smoke evacuation), and UI614 (heating + smoke evacuation + humidification).

    The tube sets are designed with a radio frequency identification (RFID) transponder technology tube set recognition function, that recognizes the type of tube set that has been connected and which functions are available based on the selection.

    AI/ML Overview

    N/A

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