BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    4K UHD Camera System

    K Number: K200216 · Decision Aug 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    12
    Review Days
    206

    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
    4K UHD Camera System
    K Number
    K200216
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scivita Medical Technology Co., Ltd.
    Date Received
    January 28, 2020
    Decision Date
    August 21, 2020
    Product Code
    HET
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HET Laparoscope, Gynecologic (And Accessories)

    Similar 510(k) Clearances

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

    SIRIUS Endoscope System (PR-SI-1230)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    i-Cut

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SIRIUS Endoscope System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Video Endoscopy System, 3D Video Endoscopy System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SurroundScope System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Scivita Medical Technology Co., Ltd.

    K Number Device Name
    K251338 Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)
    K243708 Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)
    K250210 Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))
    K240289 Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)
    K240192 Single-use Extraction Baskets
    K231521 Broncho Videoscope System
    K222812 Insufflator
    K221252 Scivita 4KINSIGHT ICG Imaging System
    K210379 Broncho Videoscope System
    K203255 4K UHD Laparoscope
    Search all 12 clearances from Scivita Medical Technology Co., Ltd. →