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510(k) Data Aggregation

    K Number
    K221124
    Device Name
    MANTIS Clip
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2022-08-04

    (108 days)

    Product Code
    PKL
    Regulation Number
    876.4400
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    K101428,K142987,K151802,K193424
    Why did this record match?
    Reference Devices :

    K101428, K142987

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

    The MANTIS Clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:

    1. Endoscopic marking
    2. Hemostasis for:
    • Mucosal/sub-mucosal defects
    Device Description

    The MANTIS Clip is a sterile device consisting of a pre-loaded, radiopaque, singleuse, endoscopic clipping device consisting of two main components: the delivery system and the clip.
    The delivery system consists of a handle assembly and delivery catheter. The deliverv system is constructed using stainless steel, and polyester materials. The delivery system will allow for the device to rotate at the distal end. The MANTIS Clip delivery system is offered in a 235cm working length. The clip consists of a stainlesssteel capsule and clip arms, a cobalt chrome yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The MANTIS Clip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device. The clip jaw teeth are designed with smaller angle between the teeth and the clip arm body.

    AI/ML Overview

    The MANTIS Clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: endoscopic marking; hemostasis for mucosal/sub-mucosal defects

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