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

    780 nm L11 LED Light Source with AIM

    K Number: K221611 · Decision Jun 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    60
    Applicant Total
    92
    Review Days
    26

    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
    780 nm L11 LED Light Source with AIM
    K Number
    K221611
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker
    Date Received
    June 3, 2022
    Decision Date
    June 29, 2022
    Product Code
    OWN
    Advisory Committee
    Gastroenterology, Urology
    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
    OWN Confocal Optical Imaging

    Similar 510(k) Clearances

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

    SmartSurgN Visualization System

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

    KARL STORZ ICG Imaging System with RUBINA® Lens

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

    cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)

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

    IMAGE1 (TC400US); X-to-4U Adapter (TC040)

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

    L12 LED Light Source with AIM

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

    VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)

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

    Other Clearances by Stryker

    K Number Device Name
    K231854 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
    K230416 Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®
    K230754 L12 LED Light Source with AIM
    K230605 1788 4K Camera System with Advanced Imaging Modality
    K230216 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
    K222130 1688 4K Camera System with Advanced Imaging Modality
    K220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem
    K221217 SPY Laparoscope
    K214046 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable
    K220895 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)
    Search all 92 clearances from Stryker →