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

    DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING SYSTEM

    K Number: K900624 · Decision Aug 2, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    243
    Same Product Code
    648
    Applicant Total
    70
    Review Days
    175

    Basic Information

    Device Name
    DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING SYSTEM
    K Number
    K900624
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    BIOSEARCH MEDICAL PRODUCTS, INC.
    Date Received
    February 8, 1990
    Decision Date
    August 2, 1990
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

    Similar 510(k) Clearances

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

    XNY Disposable Gastric Calibration Tube

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

    Flexi-Seal AIR (with ENFit Connector)

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

    hygh-tec Drainage II

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

    ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)

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

    Entarik NI Feeding Tube System

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

    CORGRIP* SR NG/NI Tube Retention System

    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)
    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. →