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

    MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM

    K Number: K980226 · Decision Feb 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    198
    Registration Numbers
    198
    Same Product Code
    353
    Applicant Total
    46
    Review Days
    27

    Basic Information

    Device Name
    MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM
    K Number
    K980226
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Received
    January 22, 1998
    Decision Date
    February 18, 1998
    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.

    Disposable Biopsy Needle

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

    Marquee™ Disposable Core Biopsy Instrument and Instrument Kit

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

    ExpressCore Biopsy Device

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

    ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

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

    Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)

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

    Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle

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

    Other Clearances by MEDICAL DEVICE TECHNOLOGIES, INC.

    K Number Device Name
    K101832 BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
    K053518 INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
    K051421 INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
    K050873 CANALIZER HYDROPHILIC GUIDE WIRE
    K043523 INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE
    K042464 V-CORE FULL CORE BREAST BIOPSY INSTRUMENT
    K040427 FIBREX CATHETER PATENCY DEVICE
    K031442 PBN GUIDEWIRES
    K021606 EN-SNARE ENDOVASCULAR SNARE AND CATHETER
    K011790 MICROCRUISER PLUS INTRODUCER SET
    Search all 46 clearances from MEDICAL DEVICE TECHNOLOGIES, INC. →