BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars

    K Number: K153258 · Decision Apr 5, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    147

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
    K Number
    K153258
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instrument Service and Savings (Dba Medline Renewal
    Date Received
    November 10, 2015
    Decision Date
    April 5, 2016
    Product Code
    NLM
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NLM Laparoscope, General & Plastic Surgery, Reprocessed

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NLM), ordered by most recent decision date.

    Reprocessed Endoscopic Trocars and Sleeves

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Reprocessed Covidien Trocar

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    REPROCESSED CLOSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Surgical Instrument Service and Savings (Dba Medline Renewal

    K Number Device Name
    K143166 Medline ReNewal Reprocessed Compression Limb Sleeves