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510(k) Data Aggregation

    K Number
    K251807

    Validate with FDA (Live)

    Date Cleared
    2026-03-06

    (267 days)

    Product Code
    Regulation Number
    876.4300
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Models FD-410LR & FD-412LR:
    The Single Use Electrosurgical Hemostatic Forceps FD-410LR/412LR are intended to be used to cauterize and coagulate or perform hemostasis using high-frequency current within the upper digestive tract in combination with an endoscope.

    Model FD-411UR:
    The Single Use Electrosurgical Hemostatic Forceps FD-411UR is intended to be used to cauterize and coagulate or perform hemostasis using high-frequency current within the lower digestive tract in combination with an endoscope.

    Device Description

    The Electrosurgical Hemostatic Forceps FD-400 series is comprised of three (3), sterile, single-use, electrosurgical hemostatic forceps of varying forceps opening widths (4 – 6.5 mm). The subject device was designed to be used with compatible endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current in the upper (Models FD-410LR and FD-412LR) and lower digestive tract (FD-411UR).
    The hemostatic forceps are attached to an electrosurgical unit via an A-cord to deliver high-frequency current to cauterize and coagulate or to perform hemostasis on the target tissue. The forceps are manufactured from stainless steel.
    The Electrosurgical Hemostatic Forceps FD-400 series is to be used with compatible electrosurgical units, A cords, and endoscopes.

    AI/ML Overview

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