LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K953355
    Device Name
    GIP/MEID-GLOBE HOT BIOPSY FORCEPS
    Manufacturer
    MEDI-GLOBE CORP.
    Date Cleared
    1996-04-04

    (262 days)

    Product Code
    KGE
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K792215,K792267,K790071,K874314
    Why did this record match?
    Reference Devices :

    K792215, K792267, K790071

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

    The intended use of the GIP Medi-Globe Hot Biopsy Forceps is identical to the Wilson-Cook device for removal of small polyps in the GI track.

    Device Description

    The GIP/Medi-Globe Hot Biopsy Forceps are similar in design, composition (stainless steel and Teflon), and function and performance to the Wilson-Cook GI Hot Biopsy Forceps. The device is designed to be used in conjunction with numerous FDA Approved endoscopes. The entire device can be autoclaved or ETO gas sterilized. The Hot Biopsy Forceps are shipped assembled and sterile in a peel-open package. The working lengths of all of the GIP/Medi-Globe Hot Biopsy Forceps range from 1,200, 1,800, 2,300.

    AI/ML Overview

    This document does not describe an AI/ML powered medical device. It describes a hot biopsy forceps, a physical medical instrument used for tissue sampling. Therefore, the requested information regarding acceptance criteria, study design, ground truth, and expert involvement for an AI/ML model is not applicable.

    The document discusses the safety and effectiveness of the GIP/Medi-Globe Hot Biopsy Forceps by comparing it to a previously cleared device (Wilson-Cook GI Hot Biopsy Forceps, K874314). The assessment is based on design, materials, intended use, method of operation, cleaning/sterilization, and biological reactivity, rather than algorithmic performance.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1