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

    CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM

    K Number: K934072 · Decision Sep 8, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    63
    Applicant Total
    18
    Review Days
    384

    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
    CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM
    K Number
    K934072
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Contour Fabricators of Florida, Inc.
    Date Received
    August 20, 1993
    Decision Date
    September 8, 1994
    Product Code
    KNY
    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
    KNY Accessories, Catheter, G-U

    Similar 510(k) Clearances

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

    Bi-Flex Evo

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

    Vesair Cystoscopic Sheath

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

    BI-FLEX URETERAL ACCESS SHEATH

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

    WIJAY EZ-VOID EXTERNAL CATHETER VALVE

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

    GUARDIAN URETHRAL SHEATH

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

    GUARDIAN URETHRAL SHEATH

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

    Other Clearances by Contour Fabricators of Florida, Inc.

    K Number Device Name
    K955685 RNS STERILE, DISPOSABLE CT BIOPSY TRAY
    K962040 RNS ARTHROGRAM TRAY
    K955687 RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY
    K955689 RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY
    K955684 RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY
    K955679 RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
    K955688 RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY
    K955686 RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY
    K955678 RNS STERILE DISPOSABLE PUNCTURE TRAY
    K955683 RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY
    Search all 18 clearances from Contour Fabricators of Florida, Inc. →