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

    ACU-MICRO-NEEDLE

    K Number: K874024 · Decision Nov 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    13
    Review Days
    52

    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
    ACU-MICRO-NEEDLE
    K Number
    K874024
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Acuderm, Inc.
    Date Received
    October 2, 1987
    Decision Date
    November 23, 1987
    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 Acuderm, Inc.

    K Number Device Name
    K933516 ACU-E PUNCH
    K933265 ACU-DISPO-CE(TM)
    K933137 ACU-SUTURE KIT
    K930043 ACU-EVAC
    K933866 ACU-HEMOSTATIC RING
    K915000 ACU-GUARD
    K891334 ACU-CURETTE
    K854877 ACU-SYRINGE W/WO NEEDLES
    K832582 MYCOSEL AGAR
    K832583 SABOURAUD DEXTROSE AGAR
    Search all 13 clearances from Acuderm, Inc. →