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510(k) Data Aggregation

    K Number
    K014002
    Device Name
    ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
    Manufacturer
    FORTUNE MEDICAL INSTRUMENT CORP.
    Date Cleared
    2002-03-04

    (90 days)

    Product Code
    KOB
    Regulation Number
    876.5090
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890

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

    The Suprapubic Catheter is intended to use for drainage of the bladder through a needle puncture or stab wound over the bladder.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to Fortune Medical Instrument Corp. for a Suprapubic Catheter. It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

    Critical information for describing acceptance criteria and a study demonstrating device performance is absent from this document. Section {0} is the FDA's acceptance letter, and Section {2} is the Indications for Use statement for the device. Neither of these sections
    contain information about:

    1. Acceptance criteria
    2. Reported device performance
    3. Details of any study (sample size, data provenance, ground truth, adjudication, MRMC, standalone performance, training set details).

    This document primarily serves as regulatory clearance, not a performance study report. Therefore, I cannot provide the requested information based solely on the provided text.

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