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

    VACUUM ASSISTED CORE BIOPSY DEVICE

    K Number: K010400 · Decision Jul 24, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    18
    Review Days
    162

    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
    VACUUM ASSISTED CORE BIOPSY DEVICE
    K Number
    K010400
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Promex, Inc.
    Date Received
    February 12, 2001
    Decision Date
    July 24, 2001
    Product Code
    KNW
    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
    KNW Instrument, Biopsy

    Similar 510(k) Clearances

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

    Promisemed VeriEcto Automatic Biopsy Needles

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

    Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char

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

    ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial

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

    EnCor EnCompass™ Breast Biopsy and Tissue Removal System

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

    Resitu Slider 09 (RESL09)

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

    Forcyte Autograft Harvest Kit

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

    Other Clearances by Promex, Inc.

    K Number Device Name
    K023450 BIOPSY SITE TISSUE MARKER DEVICE
    K022634 CO-AXIAL INTRODUCER NEEDLE
    K011270 AUTOMATED CORE BIOPSY DEVICE
    K001132 BONE BIOPSY NEEDLE
    K994272 AUTOMATED CORE BIOPSY DEVICE
    K993435 MANUAL BONE MARROW BIOPSY DEVICE
    K973184 PROSTATE SEEDING NEEDLE
    K972865 PROMEX ENT TISSUE REMOVAL SYSTEM
    K961078 AUTOMATED VITRECTOMY DEVICE
    K960023 KIRSHNER WIRES (K-WIRE) & STEINMANN PINS
    Search all 18 clearances from Promex, Inc. →