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

    MD Mattress Suture Placement Device

    K Number: K222783 · Decision Jan 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    6
    Review Days
    484

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    Basic Information

    Device Name
    MD Mattress Suture Placement Device
    K Number
    K222783
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lsi Solutions, Inc.
    Date Received
    September 15, 2022
    Decision Date
    January 12, 2024
    Product Code
    GCJ
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Lsi Solutions, Inc.

    K Number Device Name
    DEN230069 Mi-CHORD System
    K202551 Cor-Knot Micro
    K203120 RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene
    K111014 LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES
    K100593 SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME