BEUDAMED
    Product Code: OTM FDA class 2 21 CFR 878.3300

    Mesh, Surgical, For Stress Urinary Incontinence, Male

    General, Plastic Surgery

    The Mesh, Surgical, for Stress Urinary Incontinence, Male (product code OTM) is an implantable surgical mesh used for the surgical treatment of male stress urinary incontinence occurring post-prostatectomy. The mesh is designed to provide urethral support and restore continence in men who have developed incontinence following prostate removal surgery. As an FDA Class 2 device under regulation 878.3300, it requires 510(k) premarket clearance and falls within the General and Plastic Surgery specialty, reviewed by the Urology panel. The device is flagged as an implant and is not life-sustaining.

    View on FDA
    510(k)s
    12
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    7
    Years Active
    19

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    Basic Information

    Product Code
    OTM
    Device Class
    FDA class 2
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    surgical treatment of male stress urinary incontinence post-prostatectomy

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 12 510(k) clearances via K numbers.

    K Number Device Name
    K242960 AdVance™ XP Male Sling System (720163-03)
    K231891 Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
    K211847 AdVance XP Male Sling System
    K182169 AdVance XP Male Sling
    K113496 VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
    K111881 VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
    K101297 VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020
    K091152 VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020
    K082640 VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM
    K063079 I-STOP TRANS OBTURATOR MALE SLING
    K062341 MALE REMEEX SYSTEM
    K053371 AMS MALE TRANSOBTURATOR SLING SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.