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

    Apollo ESG NXT System, Apollo REVISE NXT System

    K Number: K232544 · Decision Sep 18, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    12
    Review Days
    27

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    Basic Information

    Device Name
    Apollo ESG NXT System, Apollo REVISE NXT System
    K Number
    K232544
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5983
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apollo Endosurgery, Inc.
    Date Received
    August 22, 2023
    Decision Date
    September 18, 2023
    Product Code
    QTD
    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
    QTD Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss

    Similar 510(k) Clearances

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

    APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
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    Other Clearances by Apollo Endosurgery, Inc.

    K Number Device Name
    K231553 OverStitch NXT Endoscopic Suturing System
    DEN210045 APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System
    K210266 OverStitch Sx Endoscopic Suturing System
    K201808 X-Tack Endoscopic HeliX Tacking System
    K171886 OverStitch SX Endoscopic Suturing System (ESS)
    K122270 OVERTUBE ENDOSCOPIC ACCESS SYSTEM
    K103155 SUMO ACCESS AND TISSUE RESECTION SYSTEM
    K082102 GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00
    K090583 ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165
    K082114 ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00
    Search all 12 clearances from Apollo Endosurgery, Inc. →