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

    OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES

    K Number: K942338 · Decision Nov 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    34
    Applicant Total
    142
    Review Days
    198

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    Basic Information

    Device Name
    OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES
    K Number
    K942338
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Corp.
    Date Received
    May 16, 1994
    Decision Date
    November 30, 1994
    Product Code
    FDT
    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
    FDT Duodenoscope And Accessories, Flexible/Rigid

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    Other Clearances by Olympus Corp.

    K Number Device Name
    K915402 EW-10 AND EW-20
    K933200 OLYMPUS PBD STENTS
    K931763 HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS
    K934835 FLOVAL
    K931764 HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES
    K915857 FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE
    K931994 RESECTOSCOPE SHEATH
    K933992 OLYMPUS SCLEROTHERAPY BALLOON
    K934361 OLYMPUS CREATININE REAGENT
    K934136 OLYMPUS CHLORIDE REAGENT, MODIFICATION
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