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

    RINN E-Z CAPPER

    K Number: K913885 · Decision Dec 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    5
    Review Days
    106

    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
    RINN E-Z CAPPER
    K Number
    K913885
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rinn Corp.
    Date Received
    August 29, 1991
    Decision Date
    December 13, 1991
    Product Code
    FMI
    Advisory Committee
    General Hospital
    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
    FMI Needle, Hypodermic, Single Lumen

    Similar 510(k) Clearances

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

    Profoject™ Safety Pen Needles

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Verisafe Safety Sterile Needles (SSN)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PRESSONE™

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Safety Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Rinn Corp.

    K Number Device Name
    K932134 RINN UNIVERSAL COLLIMATOR
    K828605 BEAM LIMITING DEVICE
    K813378 UNI-BITE DENTAL X-RAY FILM HOLDER
    K772313 X-RAY CO-ORDINATOR