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

    BIOMARC COAXIAL NEEDLE

    K Number: K133148 · Decision May 13, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    88
    Applicant Total
    17
    Review Days
    208

    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
    BIOMARC COAXIAL NEEDLE
    K Number
    K133148
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carbon Medical Technologies, Inc.
    Date Received
    October 17, 2013
    Decision Date
    May 13, 2014
    Product Code
    FBK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FBK Endoscopic Injection Needle, Gastroenterology-Urology

    Similar 510(k) Clearances

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

    Injection Needle

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

    InjecSURE Injection System

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

    Disposable Endoscopic Injection Needles

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

    Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)

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

    EzVu Visual Vasopressor injector (EV-19)

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

    Endoscopic Injection Needles

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

    Other Clearances by Carbon Medical Technologies, Inc.

    K Number Device Name
    K253598 InjecSURE Injection System
    K251748 MammoSTAR Biopsy Site Identifier
    K211590 Fiducial Marker
    K172227 Endoscopic Injection Needle
    K132064 BIOMARC FIDUCIAL MARKER
    K132708 BIOMARC FIDUCIAL MARKER
    K130678 BIOMARC GOLD FIDUCIAL MARKER
    K110772 BIOMARC FIDUCIAL MARKER
    K100994 PRELOADED TISSUE MARKER DEVICE
    K070436 BIOMARC GOLD TISSUE MARKER
    Search all 17 clearances from Carbon Medical Technologies, Inc. →