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

    MORE-L INJECTOR KIT PLUS

    K Number: K960619 · Decision Jun 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    154
    Applicant Total
    5
    Review Days
    128

    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
    MORE-L INJECTOR KIT PLUS
    K Number
    K960619
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5140
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Incutech, Inc.
    Date Received
    February 13, 1996
    Decision Date
    June 20, 1996
    Product Code
    CAZ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAZ Anesthesia Conduction Kit

    Similar 510(k) Clearances

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

    Arrow 0.2 Micron Flat Filter, GVS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BD Epilor Syringe

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Plastic LOR Syringe

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    E-Cath STIM acc. Tsui

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VPC

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Arrow Epidural Catheter Kit

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Incutech, Inc.

    K Number Device Name
    K951870 MORELL INJECTOR
    K942394 SAFE VENT SYSTEM
    K941731 EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET
    K940258 SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY)