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510(k) Data Aggregation

    K Number
    K091697
    Device Name
    SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015
    Manufacturer
    TRANSENTERIX, INC.
    Date Cleared
    2009-09-28

    (110 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015

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

    The SPIDER™ Surgical Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during laparoscopic procedures.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for the SPIDER™ (Single Port Instrument Delivery Extended Reach) Surgical Instruments. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    The letter from the FDA to Transenterix, Inc. confirms that their device is substantially equivalent to legally marketed predicate devices, allowing them to market it and is primarily concerned with regulatory compliance.

    Therefore, I cannot provide the requested information based on the provided text.

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