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510(k) Data Aggregation

    K Number
    K252438

    Validate with FDA (Live)

    Device Name
    Explant Express
    Manufacturer
    Applied Medical Technology, Inc.
    Date Cleared
    2026-02-03

    (186 days)

    Product Code
    QVS
    Regulation Number
    878.4675
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    DEN220082
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Explant Express™ is a single patient, single use suction device used to assist in the removal of one intracapsular ruptured silicone breast implant. Not intended for en bloc removal. Not intended to remove residual silicone or be applied directly to tissue.

    Device Description

    The Explant Express™ consists of a container with a nozzle and a port for applied suction. The scientific concept that forms the basis for the device is suction. The components of this device consist of two separable container halves and an O-ring.

    AI/ML Overview

    N/A

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