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510(k) Data Aggregation

    K Number
    K091211
    Device Name
    EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS
    Manufacturer
    ETHICON ENDO-SUGERY, LLC
    Date Cleared
    2009-09-04

    (130 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K103730,K111166,K113204
    Why did this record match?
    Reference Devices :

    K103730, K111166, K113204

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

    The ETHICON ENDO-SURGERY Single Site Laparoscopic Seal Cap Assembly with accessories and Fixed-Length Access Retractors have application in abdominal, colorectal, urologic, and gynecologic minimally invasive procedures to establish a path of entry for multiple minimally invasive instruments and for extraction of large specimens.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. The document is a 510(k) clearance letter from the FDA for a medical device called "Ethicon Endo-Surgery Single Site Laparoscopic Seal Cap Assembly with accessories and Fixed-Length Access Retractors."

    This letter primarily focuses on:

    • FDA's determination of substantial equivalence to a predicate device.
    • Regulatory classification and requirements for the device.
    • Indications for Use for the device.

    It does not include any technical specifications, performance metrics, clinical study designs, results, or data related to acceptance criteria for the device itself.

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