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510(k) Data Aggregation

    K Number
    K252892

    Validate with FDA (Live)

    Device Name
    SCOUT MD Surgical Guidance System
    Manufacturer
    Merit Medical Systems, Inc.
    Date Cleared
    2025-12-19

    (99 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    18 - 120
    Reference & Predicate Devices
    K231468
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SCOUT MD Reflector is intended to be placed percutaneously in soft tissue (>30 days) to mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SCOUT MD System) the SCOUT MD Reflector is located and surgically removed with the target tissue. The SCOUT MD System is intended only for the non-imaging detection and localization of the SCOUT MD Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

    Device Description

    The SCOUT MD Surgical Guidance System consists of the following components:

    • SCOUT MD Delivery System, which includes two components:
      • SCOUT MD Reflector
      • SCOUT MD Delivery Device
    • SCOUT MD Guide
    • SCOUT MD Single-Use Handpiece
    • SCOUT MD Console

    The SCOUT MD Delivery System is used to implant the preassembled SCOUT MD Reflector. The needle of the Delivery System is percutaneously advanced into tissue to the site to be marked for biopsy or surgical removal. Needle placement is confirmed under imaging technique (radiographic, ultrasound). The Reflector (tissue marker) is deployed at the target site and the Delivery Device is removed from the patient and discarded. The Reflector, a passive implant, remains in situ and, if surgical removal of the target tissue is necessary, the Reflector is located at the time of surgery (intraoperatively) by the SCOUT MD Surgical Guidance System. The SCOUT MD Guide/Handpiece connected to the SCOUT MD Console is used to detect the SCOUT MD Reflector but it does not contact tissue. SCOUT MD Guides are used with sterile SCOUT Guide Sheath and/or sterilized per the instructions in the IFU. When the SCOUT MD System detects the Reflector, the Console emits audible feedback that increases in cadence as the Guide/Handpiece is placed closer to the Reflector. The distance between the distal end of the Guide/Handpiece and the detected Reflector, in millimeters, is displayed on the Console. If necessary, the Reflector is removed from the patient during a subsequent surgical procedure along with the tissue of interest or the Reflector can be left in-situ.

    AI/ML Overview

    N/A

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