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

    PORGES STEPPED NEOPLEX DILATOR

    K Number: K883526 · Decision Oct 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    39
    Applicant Total
    18
    Review Days
    71

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    Basic Information

    Device Name
    PORGES STEPPED NEOPLEX DILATOR
    K Number
    K883526
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5365
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Porges Corp.
    Date Received
    August 18, 1988
    Decision Date
    October 28, 1988
    Product Code
    KNQ
    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
    KNQ Dilator, Esophageal

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    Other Clearances by Porges Corp.

    K Number Device Name
    K900269 PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE
    K900031 MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS
    K896503 PORGES ERCP CATHETERS
    K896505 PORGES UNIVERSAL HANDLES
    K896425 PORGES CYTOLOGY BRUSHES
    K896507 PORGES DIATHERMY SNARE
    K896504 PORGES 2-WAY BALLOON EXTRACTION CATHETER
    K896424 PORGES SCLEROTHERAPY NEEDLES
    K896506 PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTOR
    K896423 PORGES BILIARY STENTS
    Search all 18 clearances from Porges Corp. →