BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MD TECH BIOPSY SET FOR BONE AND BONE MARROW

    K Number: K961959 · Decision Jul 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    322
    Same Product Code
    106
    Applicant Total
    46
    Review Days
    60

    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
    MD TECH BIOPSY SET FOR BONE AND BONE MARROW
    K Number
    K961959
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Device Technologies, Inc.
    Date Received
    May 20, 1996
    Decision Date
    July 19, 1996
    Product Code
    GAA
    Advisory Committee
    General, Plastic Surgery
    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
    GAA Needle, Aspiration And Injection, Disposable

    Similar 510(k) Clearances

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

    CapnoSpot™ Pneumothorax Decompression Indicator

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MANAN ACCURA NEEDLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    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. →