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

    PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80

    K Number: K945274 · Decision Dec 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    6
    Review Days
    47

    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
    PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80
    K Number
    K945274
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pro-Tec Containers, Inc.
    Date Received
    October 28, 1994
    Decision Date
    December 14, 1994
    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 Pro-Tec Containers, Inc.

    K Number Device Name
    K945276 PRO-TEC DISPOSABLE SHARPS CONTAINERS 5G
    K945275 PRO-TEC DISPOSBLE SHARPS CONTAINERS Q1
    K945273 PRO-TECH DISPOSABLE SHARPS CONTAINERS VNC2
    K942179 PRO-TEC DISPOSABLE SHARPS CONTAINERS
    K892665 PRO-JECT(TM) SAFETY NEEDLE HOLDER