BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ATRION MEDICAL QL INFLATION DEVICE

    K Number: K032840 · Decision Mar 3, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    26
    Applicant Total
    9
    Review Days
    174

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    Basic Information

    Device Name
    ATRION MEDICAL QL INFLATION DEVICE
    K Number
    K032840
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5520
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Atrion Medical Products, Inc.
    Date Received
    September 11, 2003
    Decision Date
    March 3, 2004
    Product Code
    KOE
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KOE Dilator, Urethral

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    Other Clearances by Atrion Medical Products, Inc.

    K Number Device Name
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    K041158 ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM
    K020333 ATRION MEDICAL QL FLUID DISPENSING SYRINGE
    K973633 ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET
    K973872 ATRION MEDICAL COATED LACRIMAL INTUBATION SET
    K972964 ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE
    K971100 ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR