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510(k) Data Aggregation

    K Number
    K090796
    Device Name
    MULTI-BITE HOT BIOPSY FORCEPS
    Manufacturer
    ENDO-THERAPEUTICS, INC.
    Date Cleared
    2009-11-25

    (246 days)

    Product Code
    KGE
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MULTI-BITE HOT BIOPSY FORCEPS

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

    Biopsy forceps are intended for use in collecting tissue samples for histological examination.

    Device Description

    Multi-bite Electric (Hot) Biopsy Forceps

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Multi-bite Electric (Hot) Biopsy Forceps." It determines the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain information regarding acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone), or training set information.

    The letter confirms the device's classification and regulation, and outlines the general controls and additional controls it may be subject to under FDA regulations. The "Indications for Use" section simply states the intended use of the biopsy forceps is for "collecting tissue samples for histological examination."

    Therefore, based solely on the provided text, I cannot provide the requested information about acceptance criteria and the study proving the device meets those criteria. Such details would typically be found in the 510(k) submission itself or related study reports, not in the clearance letter.

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