BEUDAMED
    Product Code: KTI FDA class 2 21 CFR 874.4680

    Bronchoscope Accessory

    Ear, Nose, Throat

    A Bronchoscope Accessory is a device intended for use in conjunction with a bronchoscope to facilitate visualization, sampling, or therapeutic procedures within the airways and bronchial tree. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification demonstrating substantial equivalence to a legally marketed predicate device. The product code is KTI, regulated under 21 CFR 874.4680, in the Ear, Nose, Throat medical specialty. Where the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in the 510(k) submission, as required by FDA guidance (82 FR 26807).

    View on FDA
    510(k)s
    33
    FEI Numbers
    64
    Registration Numbers
    64
    Unique Applicants
    25
    Years Active
    48

    Basic Information

    Product Code
    KTI
    Device Class
    FDA class 2
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 33 510(k) clearances via K numbers.

    K Number Device Name
    K251478 ClearTip TBNA Type
    K254040 LungFlow Basket Catheter
    K251402 LIA-1 Catheter (542-1)
    K252874 Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
    K251664 Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)
    K250263 Disposable Grasping Forceps FG-52D/FG-54D
    K241679 Disposable Cytology Brush (AF series)
    K231818 METIC™- Airway Balloon Catheter
    K230778 EndoCore
    K230280 ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
    K222187 Multistage Balloon Dilatation Catheter
    K221206 Compass Steerable Needle
    K213060 AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle
    K213434 Elation Pulmonary Balloon Dilation Catheter
    K211894 Trachealator
    K193517 ViziShot 2 FLEX
    K190239 Single Use Aspiration Needle
    K181193 PeriView FLEX
    K171232 PeriView FLEX
    K170759 CRE Pulmonary Balloon Dilatation Catheter
    K163469 ViziShot 2 FLEX
    K161392 Elation Pulmonary Balloon Dilation
    K153484 Dillard Airway Dilatation System
    K152922 ViziShot FLEX
    K151522 DEFENDO Bronchoscopy Suction Valve
    K150951 aeris Balloon Dialation Catheter
    K110218 INSPIRA AIR BALLOON DILATION SYSTEM
    K090660 AIRWAY BALLOON CATHETER INFLATION DEVICE
    K082174 Y-ADAPTER
    K023337 CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350
    K020765 MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210
    K833491 ENDO BITE BLOCK
    K781365 SPARTA BRONCHIAL BRUSH

    FEI Numbers

    This FDA classification entry is associated with 64 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 64 registration numbers. Click on an entry to view related FDA registrations.