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

    BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS

    K Number: K964871 · Decision Mar 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    57
    Applicant Total
    70
    Review Days
    88

    Basic Information

    Device Name
    BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
    K Number
    K964871
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BIOSEARCH MEDICAL PRODUCTS, INC.
    Date Received
    December 5, 1996
    Decision Date
    March 3, 1997
    Product Code
    FEB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FEB Accessories, Cleaning, For Endoscope

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FEB), ordered by most recent decision date.

    CORIS System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    System 83 Revolve Endoscope Washer/Disinfector

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    enspire 3000 Cleaning and Liquid Chemical Sterile Processing System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SCOPE BUDDY PLUS Endoscope Flushing Aid

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Endoscope Reprocessor OER-Elite

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by BIOSEARCH MEDICAL PRODUCTS, INC.

    K Number Device Name
    K051480 ENTERAL FEEDING TUBE
    K970145 PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)
    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.
    K923474 LOW PROFILE GASTROMSTOMY DEVICE
    Search all 70 clearances from BIOSEARCH MEDICAL PRODUCTS, INC. →