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510(k) Data Aggregation

    K Number
    K002838
    Device Name
    GASTRIC SUCTION AND DRAINAGE CATHETER
    Manufacturer
    BIOENTERICS CORP.
    Date Cleared
    2001-07-09

    (300 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOENTERICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K964561
    Device Name
    ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA
    Manufacturer
    BIOENTERICS CORP.
    Date Cleared
    1997-02-11

    (90 days)

    Product Code
    FDG
    Regulation Number
    876.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOENTERICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENDOLUMINA® II Transillumination System is a medical device designed to aid in the identification of the esophagus, rectum, and other structures by transillumination during laparoscopy, thoracoscopy, or open procedures.
    Device Description
    The ENDOLUMINA II Transillumination System (EIB II) consists of a glass fiberoptic bundle inserted into a length of silicone elastomer tubing in a configuration similar to a fiberoptic cable. Attached to the cable's proximal end is a ball-shaped fitting which allows a clear, flexible, and detachable silicone tip to be attached or removed by means of a "pop-fit" connection. This tip is available in both blunt and tapered configurations. The EIB II is available in sizes ranging from 4 to 60 Fr. A light source connector/fitting is permanently attached to the distal end of the cable and is designed to be inserted into a commercially-available light source. Light generated from the light source is transmitted through the cable's fiberoptic bundle and down into the clear silicone tip, where it is deflected radially to enhance transillumination. The EIB II is supplied with one (1) cable assembly, which is supplied nonsterile and is designed to be reusable by the customer. Instructions for methods for cleaning and sterilizing the EIB II cable assembly are provided. The EIB II also contains three (3) detachable tips which are individually packaged in a double pouch system and labeled as sterile and for single use only.
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