BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Endo Keeper

    K Number: K152598 · Decision Mar 17, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    188

    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
    Endo Keeper
    K Number
    K152598
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nelis
    Date Received
    September 11, 2015
    Decision Date
    March 17, 2016
    Product Code
    OTJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OTJ Laparoscopic Single Port Access Device

    Similar 510(k) Clearances

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

    Uni-port

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

    CORE-SPORT

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

    AFS Medical Sterile Single-Use Access Port System

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

    FMX314 Surgical Platform

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

    ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE

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

    KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA

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

    Other Clearances by Nelis

    K Number Device Name
    K141715 GLOVE PORT