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510(k) Data Aggregation

    K Number
    K180325
    Device Name
    Single Use MultiClip Device
    Manufacturer
    Micro-Tech (Nanjing) CO., Ltd
    Date Cleared
    2018-06-01

    (116 days)

    Product Code
    PKL
    Regulation Number
    876.4400
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K152001
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Single Use MultiClip Device is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
    (1) endoscopic marking,
    (2) hemostasis for
    (a) mucosal / sub-mucosal defects

    Device Description

    The proposed device Single Use MultiClip Device is a sterile, single-use endoscopic clipping device, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it has 3 or 5 clips, the 3 or 5 clips could be continuous released by the delivery system.

    AI/ML Overview

    This document is a 510(k) Premarket Notification from the FDA regarding a medical device. It does not describe an AI/ML device or its acceptance criteria and experimental validation.

    Therefore, I cannot extract the requested information about acceptance criteria and the study proving a device meets them from this document. The document primarily focuses on the substantial equivalence of a physical medical device (Single Use MultiClip Device) to a predicate device based on its design, materials, manufacturing processes, intended use, and performance/bench testing, rather than the performance of an AI algorithm.

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