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510(k) Data Aggregation

    K Number
    K252050

    Validate with FDA (Live)

    Device Name
    Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
    Manufacturer
    Olympus Medical Systems Corporation
    Date Cleared
    2026-03-20

    (262 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Age Range
    All
    Reference & Predicate Devices
    K250957,K013591
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K250957

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Biopsy Forceps FB-211D/221D/231D/241D are intended to be used to collect tissue within the upper airways in combination with a rhino-laryngoscope.

    Device Description

    The Disposable Biopsy Forceps FB Series is comprised of four (4), sterile, single-use, disposable biopsy forceps of varying distal fenestrated cup shapes: FB-211D – Alligator jaw-step; FB-221D – Alligator jaw-step with needle; FB-231D – Oval type; and FB-241D – Oval type with needle.

    The Disposable Biopsy Forceps FB Series was designed to collect tissue within the upper airways when used in conjunction with compatible rhino-laryngoscopes to collect tissues in the upper airways. The Disposable Biopsy Forceps FB Series consists of a handle and an insertion portion. The handle consists of a handle body and slider. The insertion portion consists of a covered coil sheath (stainless steel coil operating wire and polyethylene sheath), cups, and forceps cap. The slider is connected to the operating wire in the insertion portion and the cups are opened/closed by advancing/retreating the slider with the function of the connection parts.

    AI/ML Overview

    N/A

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