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

    Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1.

    K Number: K242793 · Decision May 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    3
    Review Days
    254

    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
    Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1.
    K Number
    K242793
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Insighters Medical Technology Co., Ltd.
    Date Received
    September 16, 2024
    Decision Date
    May 28, 2025
    Product Code
    EOQ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EOQ Bronchoscope (Flexible Or Rigid)

    Similar 510(k) Clearances

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

    FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SmartClip Delivery Catheter (ADR-1715)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    FUJIFILM Ultrasonic Endoscope EB-710US

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Shenzhen Insighters Medical Technology Co., Ltd.

    K Number Device Name
    K232529 Disposable Double Lumen Endobronchial Tube
    K232580 Disposable Endobronchial Blocker Tube