LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K992362
    Device Name
    FLEXISCOPE IQ 101
    Manufacturer
    SCHOELLY FIBEROPTIC, GMBH
    Date Cleared
    1999-08-05

    (21 days)

    Product Code
    FET
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FLEXISCOPE IQ 101

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

    The Scholly Flexiscope IQ 101 is indicated for video visualization of sites in conjunction with endoscopic devices.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Schoelly Flexiscope IQ 101, an endoscope and accessories. This type of FDA letter does not include detailed studies and acceptance criteria as it's a clearance based on substantial equivalence to a predicate device, not a de novo approval or PMA which would involve extensive clinical trial data.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, and expert qualifications is not available in this document.

    The document only states:

    • Device Name: Schoelly Flexiscope IQ 101
    • Indications for Use: The Schoelly Flexiscope IQ 101 is indicated for video visualization in conjunction with endoscopic devices.

    To provide the information requested, a premarket approval (PMA) application or a de novo submission would typically be required, which would contain detailed clinical and non-clinical studies. This 510(k) merely establishes substantial equivalence to a previously cleared device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1