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

    STOMA MEASURING DEVICE

    K Number: K914482 · Decision Dec 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    47
    Same Product Code
    58
    Applicant Total
    70
    Review Days
    80

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    Basic Information

    Device Name
    STOMA MEASURING DEVICE
    K Number
    K914482
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosearch Medical Products, Inc.
    Date Received
    October 8, 1991
    Decision Date
    December 27, 1991
    Product Code
    FPD
    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
    FPD Tube, Feeding

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    Other Clearances by Biosearch Medical Products, Inc.

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    K964871 BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
    K951260 URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT
    K944614 MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM
    K932295 NON-BALLOON REPLACEMENT GASTROSTOMY KIT
    K935045 BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER
    K923002 ENTEROCLYSIS TUBE
    K934193 CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST
    K922987 LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC.
    Search all 70 clearances from Biosearch Medical Products, Inc. →