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

    NEZHAT-DORSEY(TM) REUSABLE ASPIRATION-VAC(TM) PROBES WITH AND WITHOUT PUNCTURE CANNULA

    K Number: K946089 · Decision Mar 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    18
    Review Days
    83

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NEZHAT-DORSEY(TM) REUSABLE ASPIRATION-VAC(TM) PROBES WITH AND WITHOUT PUNCTURE CANNULA
    K Number
    K946089
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Hydro-Surgical Instruments, Inc.
    Date Received
    December 13, 1994
    Decision Date
    March 6, 1995
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

    Similar 510(k) Clearances

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

    FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)

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

    “Tech-Image” Video Endoscope System

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

    TroKit Laparoscope Lens Wiper

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

    Inno-Port Disposable Bladed Trocar

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

    4K NIR/ICG Imaging System

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

    MediBot Needle Driver Uno

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

    Other Clearances by American Hydro-Surgical Instruments, Inc.

    K Number Device Name
    K953574 NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER
    K953481 NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER
    K952070 NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS
    K946380 NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)
    K951300 NEZHAT-DORSEY THERMAL RETENTION SYSTEM
    K950499 NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS
    K951119 NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM
    K952421 NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS
    K951733 NEXHAT-DORSEY PENCIL-GRIP TRUMPET VALVE WITH CUTTING AND COAGULATION HAND CONTROLS
    K951732 NEZHAT-DORESEY PENCIL-GRIP HANDLES
    Search all 18 clearances from American Hydro-Surgical Instruments, Inc. →