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

    ENDOMAXX FULLY COVERED ESOPHAGEAL STENT

    K Number: K111611 · Decision Jul 29, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    58
    Applicant Total
    178
    Review Days
    50

    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
    ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
    K Number
    K111611
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3610
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merit Medical Systems, Inc.
    Date Received
    June 9, 2011
    Decision Date
    July 29, 2011
    Product Code
    ESW
    Advisory Committee
    General, Plastic Surgery
    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
    ESW Prosthesis, Esophageal

    Similar 510(k) Clearances

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

    Niti-S Esophageal Stent; Esophageal TTS Stent

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HANAROSTENT Esophagus Upper (CCC)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Resilience Fully Covered Esophageal Stent System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Agile Esophageal Stent System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Esophageal TTS Stent

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Merit Medical Systems, Inc.

    K Number Device Name
    K254073 StatSeal Disc
    K251802 STAR RF Ablation System
    K252892 SCOUT MD Surgical Guidance System
    K250853 Merit Syringe
    K251265 Resilience Fully Covered Esophageal Stent System
    K250909 Prelude Wave Hydrophilic Sheath Introducer
    K242873 Ventrax™ Delivery System
    K242229 Micro Ace Gold Advanced Micro Access System
    K241521 Prelude Small O.D. Introducer Guide Wire
    K233268 Impress Angiographic Catheter
    Search all 178 clearances from Merit Medical Systems, Inc. →