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

    IOPSY TRAY FOR SOFT TISSUE BIOPSY

    K Number: K771784 · Decision Nov 30, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    322
    Same Product Code
    106
    Applicant Total
    632
    Review Days
    68

    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
    IOPSY TRAY FOR SOFT TISSUE BIOPSY
    K Number
    K771784
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    September 23, 1977
    Decision Date
    November 30, 1977
    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 Bd Becton Dickinson Vacutainer Systems Preanalytic

    K Number Device Name
    K003062 BACTEC MGIT 960 SIR KITS
    K003553 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
    K003461 BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
    K002938 B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16
    K001364 BD DIRECTIGEN FLU A+B
    K000762 MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
    K000829 GATIFLOXACIN, 5 UG, BBL SENSI-DISC
    K993186 SYNERCID, 15 UG, BBL SENSI-DISC
    K992734 BECTON DICKINSON SYRINGE
    K991551 VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
    Search all 632 clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic →