LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K970107
    Device Name
    INTUBATION ENDOSCOPE AND INTRODUCER SHEATH
    Manufacturer
    UROHEALTH SYSTEMS, INC.
    Date Cleared
    1997-11-18

    (309 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    INTUBATION ENDOSCOPE AND INTRODUCER SHEATH

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

    The Intubation Endoscope and Introducer Sheath are used in the direct visualization in the trachea and lungs during fiberoptically assisted intubation and airway management.

    Device Description

    UROHEALTH Intubation Endoscope Introducer Sheath is a device that consists a malleable or nonmalleable introducer sheath that houses a channel for insufflation of oxygen or fluid delivery, a deflecting mechanism for the distal tip, a channel for scope insertion, and a distal window. The reusable fiber optic imaging and illumination system consists of a focusing ocular lens, a distal objective lens, and a connection for a fiber optic light cable.

    AI/ML Overview

    The provided 510(k) summary for K970107, the UROHEALTH Intubation Endoscope and Introducer Sheath, describes performance testing but does not present specific acceptance criteria or detailed study results in a quantitative manner as typically expected for device performance. It outlines the types of tests to be conducted rather than reporting the outcomes against defined metrics.

    Here's a breakdown based on the provided text, addressing your points:

    1. A table of acceptance criteria and the reported device performance

    Based on the provided text, specific quantitative acceptance criteria and reported device performance are not available. The summary states:

    Acceptance Criteria (Implied)Reported Device Performance
    Integrity of sterile barrier under normal usage conditions"will be tested to ensure integrity of the sterile barrier under normal usage conditions." (No specific results or metrics provided).
    Integrity of all bonded joints based on appropriate ASTM procedure"All bonded joints will tested according to the appropriate ASTM procedure." (No specific results or metrics provided).
    Biocompatibility (cytotoxicity, sensitization, irritation) in accordance with EN 30993 for medical devices with mucosal membrane contact (
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1