LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K012224
    Device Name
    SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW
    Manufacturer
    RANFAC CORP.
    Date Cleared
    2001-08-22

    (67 days)

    Product Code
    KNW,FCG
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW

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

    The Ranfac Single Action Biopsy Needle is intended for obtaining a percutaneous soft tissue biopsy.

    Device Description

    Ranfac Single Action Biopsy Needle

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, or how ground truth was established for a medical device.

    The document is a 510(k) clearance letter from the FDA for a "Ranfac Single Action Biopsy Needle." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

    It primarily focuses on:

    • Device Name: Ranfac Single Action Biopsy Needle
    • Regulation Number: 876.1075
    • Regulatory Class: II
    • Product Code: KNW, FCG
    • Date: August 22, 2001
    • Indications For Use: Obtaining a percutaneous soft tissue biopsy.
    • Regulatory process: Confirmation of substantial equivalence based on the 510(k) submission.

    Therefore, I cannot provide the requested table or answer the specific questions based on this input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1